Life Sciences and Healthcare


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 Webinar Id:  HIPJPTH001
 12:30 PM PT | 03:30 PM ET
 12/12/2017
 Duration: 60 mins

HIPAA Privacy Rule Use and Disclosure Misconceptions

With the complexity of the Privacy Rule and the frequent changes to it, healthcare covered entities and their business associates often do not know what uses and disclosures the Privacy Rule permits. Not knowing when you can disclose health information This can result in can result in bad outcomes, including the death of the patient/client, lawsuits for breach of confidentiality, HIPAA civil money penalties, and bad publicity, as well a........


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     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCBP002
 12:30PM PT | 03:30PM ET
 12/12/2017
 Duration: 60 mins

Produce Safety: The Enigma of a Healthy Diet (Popeye Would Turn Over in his Grave)

In the United States, more illnesses have been attributed to leafy vegetables (22%) than to any other commodity: illnesses associated with leafy vegetables are the second most frequent cause of hospitalizations (14%) and the fifth most frequent cause of death (6%). This situation is probably reflected globally. Should we stop eating all raw fruit and vegetables? Does washing make it safer? Are we putting ourselves at risk by eating our ........


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     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCPF001
 10:00 AM PT | 1:00 PM ET
 12/12/2017
 Duration: 90 mins

Fighting butterflies & presenting with finesse

This webinar will help you bring the visual element to your presentations, along with the ease of presentation. Learn how to captivate your audience, communicate your message, and have fun!


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCGJ002
 10:00 AM PT | 01:00 PM ET
 12/12/2017
 Duration: 60 mins

Strategies for Billing Medicare For DME-From getting DME PTAN # to Full Accreditation

Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines. Then learn how to get fully Accredited that can grow your business dramatically!! Key strategies of a successful program Understan........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCSJA022
 10:00 AM PT | 01:00 PM ET
 12/13/2017
 Duration: 60 mins

Strategies for Becoming a Business Partner to Your Healthcare Leaders.

All too often compliance is seen as an obstacle or otherwise viewed negatively by healthcare leaders. This presentation will discuss strategies and insights to help the compliance officer position himself or herself to becoming a business partner to those in operations. Mr. Anstine will focus on several key strategies you can take to help change the perception of compliance in your organization.  


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCDT001
 10:00 AM PT | 1:00 PM ET
 12/14/2017
 Duration: 60 mins

Motivation Innovation: The Latest on Carrots vs. Sticks

It is one thing to know how to alter one's behavior, but it is an entirely different matter to be motivated to do so. It is felt that employee motivation is the key factor in determining the success or failure of worksite wellness programs and their ability to reduce health care costs and increase productivity. Health professionals have developed many behavioral techniques to help employees make lifestyle changes. Despite these methodol........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCGJ001
 10:00 AM PT | 01:00 PM ET
 12/14/2017
 Duration: 60 mins

How Doctors of Chiropractic Can Bill Medicare Legally for DME

Can a Doctor of Chiropractic really bill Medicare for DME? It is not if but how Explore the strategies to be able to provide your Medicare patients with Durable Medical Equipment Develop great patient clinical outcomes and a great revenue stream that it is legally compliant. Lower healthcare costs by preventing unnecessary surgeries. Learn how to get the proper licensure and how to be compliant with all Federal & State Guidelines. How t........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPBPH003
 12:30 PT | 03:30 ET
 12/15/2017
 Duration: 60 mins

HIPAA Awareness and Security Training for Covered Entities & Business Associates

This webinar will explain the importance of HIPAA, outlines the requirements related to protecting personal health information (PHI), and specifies best practices for the handling of such information. It focuses on Businesses associates (and their sub-contractors) and their responsibilities under HIPAA as well as the Covered Entity responsibilities to monitor their BAs Business associates and their subcontractors face potential liabilit........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPOJPT001
 12:30 PM PT | 03:30 PM ET
 01/11/2018
 Duration: 60 mins

Omnibus (Mega) Rule Changes to HIPAA & the HITECH Act and What They Mean to Covered Entities and Business Associates

The Omnibus or Mega Rule, implementing the HITECH Act of 2009 significantly changed HIPAA compliance. Although it has been in effect for some time now, some of the drastic changes are still causing covered entities and business associates significant difficulties.


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCCP008
 12:30 PM PT | 03.30 PM ET
 01/12/2018
 Duration: 60 mins

Understanding Design Controls

Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throu........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCWT001
 10:00AM PT | 01:00PM ET
 01/16/2018
 Duration: 60 mins

How to Design and Implement a Dynamic Control Plan

Failure mode effects analysis (FMEA) and the control plan, which describes controls for critical-to-quality (CTQ) process activities, are both important elements of advanced quality planning (AQP). The FMEA's outputs, which include identification of the CTQ activities, define the control plan so it comes almost naturally to add columns to the FMEA to include the control plan. The result is a dynamic control plan; a living document that ........


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     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CICME004
 12:30 PM PT | 03:30 PM ET
 01/18/2018
 Duration: 90 mins

How Can Employers Navigate the New EEOC Strategic Priorities for 2017-2020 and Mitigate New Regulations! See What Regulations Will Impact Employers!

"Free Federal Poster Compliance Checklist for all attendees to assist in poster compliance" The Equal Employment Opportunity Commission (EEOC), the enforcement arm for the Equal Employment Opportunity (EEO) who protects employees in the workplace of discrimination with the authority to investigate, make charges, conduct workplace audits and levy penalties. The EEOC also provides guidance and tools to assist certain Employers to ensure t........


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       $179
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(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPNBLT001
 10:00 AM PT | 01:00 PM ET
 01/18/2018
 Duration: 90 mins

New HIPAA Updates for 2018 Covering 2017 Changes

This HIPAA 2018 changes and updates session will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA has become fully enforced and the government is not using kid gloves anymore. It will even handle key updates under the Omnibus Principle, Trump administration and every other appropriate changes for 2018 and beyond. You will find an enormous level of dilemmas and risks for ........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPHJPT001
 12:30 PM PT | 03:30 PM ET
 01/18/2018
 Duration: 60 mins

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the nece........


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     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPHBLT001
 10:00 AM PT | 01:00 PM ET
 01/23/2018
 Duration: 90 mins

HIPAA changes 2018 and How to comply?

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates the........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCJI001
 12.30 PM PT | 03.30 PM ET
 01/23/2018
 Duration: 60 mins

IDMP: Data Collection

This session will review the basic requirements of the initial planned European implementation of the ISO IDMP standard, then explore how the data for a product could be gathered for entry into a RIM system or what is expected in the agency web portal. Benefits of integration in a RIM environment, and downstream use of the data, will be covered.


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPHJT006
 10:00 PT | 01:00 ET
 01/25/2018
 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy and Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspectiv -from a personal perspective - from the perspective of the person in charge of moving an organization or facility ........


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(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CIFWJK001
 12:30 PM PT | 03:30 PM ET
 01/29/2018
 Duration: 60 mins

8 Ways to Reduce the Cost of Your RoHS/REACH Compliance Program

The Webinar will propose several practical methods a manufacturer might implement to make their material compliance efforts more effective. The material regulations are expanding and becoming more inclusive. These changes are increasing the negative impact of RoHS and REACH compliance on manufacturers. To mitigate increasing cost and risk there are several potential process enhancements that might be implemented by manufacturers. In thi........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJP007
 12:30 PM PT | 03:30 PM ET
 01/30/2018
 Duration: 60 mins

How to Handle HIPAA Security Incidents, Breaches, Complaints, and Investigations

With the Enactment of the Modifications to HIPAA contained in the so called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCWR001
 10:00AM PT | 01:00PM ET
 02/01/2018
 Duration: 60 mins

Reduce Inspection Costs with Sequential Sampling

ANSI/ASQ Z1.4 (formerly MIL-STD 105) is a generally accepted standard for acceptance sampling by attribute (pass/fail) data. Sampling plans are defined by a sample size of n and an acceptance number c, and lots are accepted if the sample contains c or fewer nonconformances or defects. Double sampling and multiple sampling plans seek to reduce the amount of inspection by accepting very good lots quickly, and rejecting very bad lots just ........


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(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTR001
 12:30 PM PT | 03:30 PM ET
 02/13/2018
 Duration: 60 mins

Road to HIPAA Compliance: How to Handle HIPAA and HITECH Security Breaches, Complaints, and Investigations

With the Enactment of the Modifications to HIPAA contained in the so called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........


View Details

       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCHWL003
 10:00 AM PT | 01:00 PM ET
 02/13/2018
 Duration: 60 mins

How to Perform Measurement Systems Analysis

Measurement systems analysis (MSA) is the counterpart of calibration. Calibration ensures the accuracy of gages and instruments, while MSA measures their precision. Accuracy reflects the gage's ability to, on average, return the actual dimension of the part on which it is used. Precision measures the gage's ability to get consistent measurements from a given part. Both are important elements of metrology. This presentation will show how........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CKHPH001
 10:00 AM PT | 01:00 PM ET
 02/14/2018
 Duration: 60 mins

HIPAA and Patient Engagement - Easy-to-Follow Rules for Web Sites & Social Media.

Patient Engagement is a cornerstone of quality patient care and Web Sites and Social Media are widely used to communicate with patients. HIPAA law still applies but is misunderstood by most health care providers and business associates in relation to patient communications. This webinar provides the guidance needed to use Web Sites and Social Media in healthcare.


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CKCP002
 10:00 AM PT | 01:00 PM ET
 02/15/2018
 Duration: 60 mins

Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing

Objectionable microorganisms are considered,  if discovered, harmful to the patient. By identifying and controlling these microorganism and putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionab........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CKHPH002
 10:00 AM PT | 01:00 PM ET
 02/22/2018
 Duration: 60 mins

HIPAA and Patient Engagement - Easy-to-Follow Rules for Email & Text Messaging.

Patient Engagement is a cornerstone of effective patient care. Communication technology offers indispensable patient engagement tools. Secure patient portals are available. So are encrypted text message and email products. But patients overwhelmingly choose non-secure communication tools like text messaging and email. Appointment reminders, healthcare instructions, patient satisfaction surveys, health and wellness newsletters and recall........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  LSHCGJS003
 10:00 AM PT | 01:00 PM ET
 02/22/2018
 Duration: 60 mins

How To Increase Your Revenues By Billing for DME & Stay Legally Compliant

Learn that treating your patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs form unnecessary surgeries and faster rehabilitation. However one must know how to get the proper licensure and know the Federal & State Guidelines. You must know how to prepare to deal with the insurance companies that constantly deny every ........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPHJPT002
 12:30 PM PT | 03:30 PM ET
 02/22/2018
 Duration: 60 mins

How to do a HIPAA and HITECH Risk Analysis

After explaining the need for conducting a HIPAA risk analysis and the penalties for not doing so, this Webinar will provide attendees a methodology for doing so. HIPAA does not specify a particular way of conducting such an analysis. But the author has taken hundreds of covered entities and business associates through the process and his way of doing must work because none of them have had a security breach.


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTW007
 12:30 PM PT | 3:30 PM ET
 03/06/2018
 Duration: 60 mins

What Is a HIPAA Security Incident and What Should You Do about It?

With the Enactment of the Modifications to HIPAA contained in the so-called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........


View Details

       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTW006
 12:30 PM PT | 3:30 PM ET
 03/20/2018
 Duration: 60 mins

What Does the Term "Reasonable and Appropriate" Mean under HIPAA? And How Do You Achieve It?

The HIPAA Security Rule requires covered entities and business associates to implement "reasonable and appropriate" security measures to protect against improper access, use, or disclosure of Protected Health Information ("PHI"). The Rule, however, gives very little guidance as to what constitutes reasonable and appropriate security measures. This is probably a good thing because what is reasonable and appropriate for a small town denta........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTH005
 12:30 PM PT | 3:30 PM ET
 03/29/2018
 Duration: 60 mins

HIPAA Breach Notification Rule - What you must do to Comply

With the Enactment of the Modifications to HIPAA contained in the so-called HI-TECH Act and its implementing regulation, the Omnibus Rule, the law and DHHS have greatly expanded the importance of handling breaches properly. How covered entities handle security incidents, breaches, and complaints is one of the key areas that DHS audits for. In addition, it has imposed civil money penalties as high as $5.5 million for failure to handle HI........


View Details

       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTH002
 12:30 PM PT | 03:30 PM ET
 04/05/2018
 Duration: 60 mins

HIPAA Compliance Through Policies

The webinar will explain the process for covered entities and business associates to use to draft, adopt, and implement HIPAA compliance policies. Writing a policy is easier than one may think. It is a three-step process: researching, drafting and revising. This webinar will teach you to ask questions, solicit help, collect samples, keep the principles of substance, organization, coherence, style, and correctness in mind while you are d........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  CKHPH003
 10:00 AM PT | 01:00 PM ET
 04/18/2018
 Duration: 60 mins

Business Associates Come in From the Cold! 5 Steps to HIPAA Compliance.

HIPAA law applies to Business Associates (BAs) in healthcare - BAs are organizations that create, receive, maintain or transmit Protected Health Information (PHI) - on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity - and are directly liable for compliance with HIPAA law protecting the privacy and security of PHI.


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTH003
 12:30 PM PT | 03:30 PM ET
 04/19/2018
 Duration: 60 mins

How to do a HIPAA Risk analysis

After explaining the need for conducting a HIPAA risk analysis and the penalties for not doing so, this Webinar will provide attendees a methodology for doing so. HIPAA does not specify a particular way of conducting such an analysis. But the author has taken hundreds of covered entities and business associates through the process and his way of doing must work because none of them have had a security breach.


View Details

       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id:  HIPJPTH004
 12:30 PM PT | 03:30 PM ET
 05/08/2018
 Duration: 60 mins

HIPAA Issues in Mental and Behavioral Health

This webinar is not a total guide to HIPAA compliance. Total HIPAA compliance includes information on the standard transactions and code sets, identifiers, how to handle breaches, and the like. This webinar focuses on HIPAA's Security Rule and Privacy Rule compliance to enable mental and behavioral health professionals to effectively treat their clients without violating HIPAA's complex individual rights standards and disclosure standar........


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       $179
  Single Attendee
(Only for one Participant)
     $363
Multiple Attendee
( 2 - 5 Participants)
     $726
Corporate Attendee
( 6 - 10 Participants)
       $237
    Recorded
(6 months unlimited access)
 Webinar Id: LSHCRC007
 View Anytime
 Duration: 60 mins

CMO Supplier Quality Agreements :- How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturer

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing A........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCWLP001
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 Duration: 60 mins

Paying for Referrals: Risky Behavior

The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. We will prov........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPNAK002
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 Duration: 60 mins

HIPAA Compliance in Light of Recent Enforcement Actions.

This webinar will examine recent HIPAA enforcement actions and trends and will discuss practical insights on HIPAA from such enforcement activities. The webinar will cover HIPAA hot topics, as reflected in enforcement actions, and will provide guidance on avoiding enforcement actions.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCUJA021
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 Duration: 60 mins

Understanding the Decision Points of Self-Disclosures and Repayment Obligations.

Historically, providers and suppliers enrolled in federal government healthcare programs have reconciled and returned overpayments through various post-payment audits. Additionally, these same entities have voluntarily returned self-identified overpayment through various self-disclosure methods made available to them. When Congress passed the Fraud Enforcement Recovery Act of 2009 ("FERA"), these self-identified disclosures went from st........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPJSF001
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 Duration: 60 mins

Fund Raising for Organizations Governed by HIPAA

Organizations that are covered by HIPAA are also governed by special rules when fundraising for that organization. Any health care institution that fund raises or clinical providers who assist in fund raising are affected by these federal regulations.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCWP001
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 Duration: 60 mins

Process Capability Analysis, and What to Do if it's Not a Bell Curve

The process capability index, and related process performance index, reflect the ability of a manufacturing process to meet specifications. A Six Sigma process has six process standard deviations between the specification limits and the nominal. The traditional process capability indices, however, rely on the assumption that the process follows a normal (bell curve) distribution. When this is not the case, special but off the shelf meth........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPHPH008
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 Duration: 60 mins

HIPAA Risk Analysis - Risk Management - Explained & Demonstrated

The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS) has just announced alarming results of the Phase 2 Covered Entity HIPAA Compliance Audits. 94% failed the Risk Management Audit and 87% failed the Risk Analysis Audit! Every audited Covered Entity knew well in advance that it was on the short list to be audited, had completed pre-audit questionnaires and knew the exact........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCMEW007
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 Duration: 90 mins

Conducting a Software Validation of Medical Device to Meet FDA Requirements

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCHWMC003
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 Duration: 60 mins

Healthcare Quality Improvement Act - Achieving Immunity in Your Peer Review Process

This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the act. Next will be a review of the standards under the act.........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCFP001
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 Duration: 90min mins

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling,and documentation requirements will also be reviewed and explored.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCMC001
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 Duration: 60min mins

CAPA: Corrective and Preventative Actions and Addressing Non-Conformances

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory, how do you approach it? Do you jum........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBPH007
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 Duration: 60 mins

Business Associates 2018 - Top 5 HIPAA Compliance Priorities

Business Associates - organizations that create, receive, maintain or transmit Protected Health Information (PHI) - on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity - are directly liable for compliance with HIPAA law protecting the privacy and security of PHI. If you are a Business Associate you must know exactly what you have to do to comply with HIPAA. But you have two hurdles. 

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPNAK003
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 Duration: 60 mins

HIPAA Basics for Non - Healthcare People

This webinar will provide a broad overview of HIPAA, including its applicability, its general rules, and requirements for compliance.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCRC005
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 Duration: 60 mins

Pharmaceutical Compressed Air :- Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCTJA014
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 Duration: 60 mins

Tis the Season: Navigating the Compliance Challenges with Holiday Gifts

This webinar is designed to help attendees navigate through the compliance challenges related to holiday gift giving and receiving with physicians, vendors, patients, and co-workers. More specifically, it will discuss the regulatory framework surrounding gifts, common gifting scenarios, the pitfalls to avoid, and strategies for drafting organizational gift policies.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCCB003
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 Duration: 90 mins

Regulatory Compliance and Culture Change

CMS regulations have always supported the principles and practices of culture change and now even more so. See how the new CMS regulations support culture change practices and how the national culture change movement affected the new requirements .Learn how a transformed culture centered around resident autonomy and regard, naturally meets regulations. It is our time to now only link culture change to the new CMS requirements but levera........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCMEW006
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 Duration: 90 mins

MDR Program conforming to New FDA Guidance

This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include death, injury and malfunction reporting requirements, record keeping requirements, report timing, clarification of the term "becoming aware" and clarification of reporting using electronic form 3500A.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCGCP005
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 Duration: 60 mins

GMP Auditing for Pharmaceutical Manufacturing.

Auditing involves a comprehensive review of vendors that will provide resources and/or services. The ICH Q10 document provides an outline on the pharmaceutical drug product life-cycle. Through the review of ICH Q8, Q9, and Q10, the participant will be able to audit the various activities associated with the different stages of the product lifecycle. By using a scientific risk-based approach, as outlined in ICH Q9, the participant will b........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCMEW005
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 Duration: 90 mins

Medical Device Premarket and Post market Cyber security following the new FDA Guidances

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices. All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBPH001
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 Duration: 75 mins

HIPAA - The Do's and Don'ts of Social Media and HIPAA Compliance

Hundreds of hospitals and other healthcare institutions across the nation are embracing social media. But how risky is this from a HIPAA and HITECH compliance stand point is this practice? Are you doing all you can/should to be compliant and manage/reduce the risk of a breach of PHI in your institution? By federal law PHI must be secured and its privacy insured. How do open, very public forums like Facebook, Twitter, LinkedIn mesh with ........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPMPH004
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 Duration: 60 mins

MACRA & MIPS - Patient Engagement Part 1 - HIPAA Rules for Web Sites & Social Media

There are widespread violations of the HIPAA Rules for communicating with patients by unencrypted email and text message - largely because Providers and Business Associates just don't know the rules - and don't understand what PHI really is - as defined by HIPAA. The HIPAA Rules and HHS/OCR guidance provide a simple, easy to use 3 Step Safe Harbor for using unencrypted email and text messaging to engage patients. This session will expla........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCWA001
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 Duration: 90 mins

Writing Effective SOP’s

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCTK002
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 Duration: 60 mins

Human Factors Engineering in New Product Development

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCPBA001
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 Duration: 90 mins

Advertising and Promotional material compliance and review process

This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented. Ensure that your company has a program in place that will ensure full understanding and communication of potential risks associated with materials and ability to mitigate risk through subtle but important modifica........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPNAK001
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 Duration: 60 mins

HIPAA And Litigation - Getting and Producing Records Through Discovery

This webinar will examine the interplay between HIPAA and state law when it comes to requesting and producing health records in the context of litigation. The webinar will address how attorneys should properly request health records and how covered entities and business associates should properly respond to such requests.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LHSCDRD002
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 Duration: 60 mins

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

The session will provide an understanding and overview of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Gain experience and learn more about detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. The issue of fraud is again a focus within the clinical research industry. Although high-profile cases tend to periodically........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPHJ005
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 Duration: 60 mins

The Roles and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance.  This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facili........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCP006
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 Duration: 60 mins

Preventing Medical Device Recalls ? A Prevention Strategy

In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2016 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients. The increase indicates serious failures in the processes and controls designed to ensure reliability, safety, and effectiveness of the recalle........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCHJA019
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 Duration: 60 mins

Healthcare Fraud: Current Legislative and Regulatory Update.

This presentation will provide a general overview of the key legislative and regulatory developments in the area of healthcare fraud and abuse. For the key regulatory developments, Mr. Anstine will walk through notable cases to highlight key takeaways attendees should be aware of relative to help safeguard the operations of their own organizations.  

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT008
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 Duration: 90 mins

HIPAA - New Risks for the Business Associate

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance.  I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.  Times have changed and unfortunately many businesses are losing clients or un........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCMEW004
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 Duration: 60 mins

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCSDD005
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 Duration: 60 mins

Course Description - How to Write and Manage a Change Control System

This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCAWL002
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 Duration: 60 mins

Acceptance Sampling for Variables (ANSI/ASQ Z1.9)

ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a generally accepted standard for acceptance sampling by variables (real number) data. The sampling plans work by (1) calculating the sample's average along with a measurement of dispersion (standard deviation or range) and (2) comparing these results against tabulated criteria to determine whether the lot should be accepted or rejected. Switching rules similar to those of ANSI/ASQ Z1.4 (formerly ........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCPJA018
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 Duration: 60 mins

Protecting Your Organization Against Sanctions for Ineffective Exclusion Screening.

Under certain circumstances (such as convictions for patient abuse and violations of the anti-kickback statute), the Department of Health and Human Services, Office of Inspector General ("OIG") is required to exclude persons from federal healthcare programs (e.g. Medicare, Medicaid). In other circumstances,(such as civil and criminal violations of healthcare laws), the OIG has the discretion to exclude an individual from a federal healt........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCRG001
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 Duration: 60 mins

Import FDA in the Automated Commercial Environment (ACE) Authorized Electronic Data Interchange (EDI) System

It focuses on the role of the import managers when shipping goods under the FDA and Customs Regulations. It also addresses what regulations can be used to help the importer in understanding Automated Commercial Environment (ACE)as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings Accompanied by Food and Drug Administration (FDA) Data. This review FDA report........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCACP003
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 Duration: 60 mins

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing.

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBPH002
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 Duration: 60 mins

HIPAA 101 - The basics of HIPAA Compliance

What HIPAA is and what are the key MUST do's to be in compliance and avoid "willful neglect" in an audit.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCLJA013
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 Duration: 60 mins

Looking Inward: Assessing the Effectiveness of Your Compliance Program.

This webinar is designed to walk attendees through a self-assessment of the effectiveness of his/her compliance program to determine if the program is meeting the Federal government's standards (e.g. The Office of Inspector General's "Seven Elements of an Effective Compliance Program"). More specifically, this presentation will walk through a checklist of questions directed at each of the seven elements and offer strategies and tips for........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT009
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 Duration: 90 mins

What to Expect in a Federal HIPAA Audit and How to be Prepared

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received.This lesson will be addressing how to p........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPJHT001
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 Duration: 90 mins

How to Handle HIPAA and HITECH Act Breaches, Complaints and Investigations: Everything You Need to Know

This webinar will inform covered entities and business associates how to handle security incidents. Almost every one of those entities will have one or more security incidents a year but they may or may not be a breach that they must take further action on. The webinar will spell out what actions must be taken in the event of an incident or breach and also how to handle complaints by patients/clients and what to do if investigated to av........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCSDD004
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 Duration: 60 mins

Steam Sterilization Microbiology and Autoclave Performance Qualification

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPSKH003
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 Duration: 60 mins

How to survive a HIPAA audit by HHS/OCR

The OCR HIPAA Audit is a mandate under the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HIPAA audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification. Privacy Rule requirements for  Notice of privacy ........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT010
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 Duration: 90 mins

HIPAA & the Compliance Officer

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.  Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.  The primary goal is to ensure everyone is well educate........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCCB001
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 Duration: 90 mins

CMS Reform of LTC Requirements: Final Rule

CMS issued the Reform of Requirements for LTC Facilities: Final Rule in Sept. 28, 2016. Phase I implementation was already required by Nov. 28, 2016. Phase 2 is to be implemented by Nov. 28, 2017. Is your home ready? Learn the new requirements (last regulation changes were in 1991) - what's new and what remains, as well as some culture change wins. Together we'll brainstorm ways to comply that don't cost a lot of money; many culture cha........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCTK001
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 Duration: 60 mins

How Home Healthcare is Changing the Medical Device Game

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPAB001
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 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Compliance Certification

HIPAA, which stands for Health Insurance Portability & Accountability Act, does not just apply to health insurance. The rules apply to all companies with Personal Health Information (PHI) in electronic formats -doctors, health plans, pharma organizations, government programs, research organizations, testing organizations, pharmacies, clinics, IT services for regulated organizations, and more. In March of 2013, the HIPAA Omnibus Final Ru........

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 Webinar Id: HIPJMB001
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 Duration: 60 mins

HIPAA Issues in Mental and Behavioral Health

This webinar is not a total guide to HIPAA compliance. Total HIPAA compliance includes information on the standard transactions and code sets, identifiers, how to handle breaches, and the like. This webinar focuses on HIPAA's Security Rule and Privacy Rule compliance to enable mental and behavioral health professionals to effectively treat their clients without violating HIPAA's complex individual rights standards and disclosure standar........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT011
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 Duration: 90 mins

HIPAA Audits - an Insiders Perspective.

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing how pra........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT012
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 Duration: 90 mins

Do's and Don'ts Regarding HIPAA Texting and Emailing

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

$243  Recorded  (6 months unlimited access)

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 Webinar Id: LHSCMJA014
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 Duration: 60 mins

Medical Director Contracting: Key Pitfalls to Avoid.

This webinar will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.  

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT013
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 Duration: 90 mins

Managing Risks Under HIPAA - HITECH

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak o........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPHHSK003
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 Duration: 60 mins

HIPAA-HITECH Assessment of your Cloud Service Providers

The primary objective of this 60 minute webinar is to help organization identify the key vulnerabilities with cloud service providers by reviewing the best practices to evaluate, engage and monitor online service providers to protect ePHI handled on behalf of the Covered Entity. Have you identified the e-PHI with your cloud service providers? This includes e-PHI that you create, receive, maintain or transmit. What are the external sourc........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCAB003
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 Duration: 90 mins

Sharps Safety Program: Risks, Prevention & Management of Sharps Injuries

Occupational exposure to blood borne pathogens from needle sticks and other sharps injuries is a serious problem, but it is often preventable. The Centers for Disease Control and Prevention (CDC) estimates that each year 385,000 needle sticks and other sharps related injuries are sustained by hospital-based healthcare personnel. Similar injuries occur in other healthcare settings, such as nursing homes, clinics, emergency care services,........

$277  Recorded  (6 months unlimited access)

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 Webinar Id: HIPKO001
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 Duration: 60 mins

We Had a HIPAA Breach - Now What Do We Do?

This webinar will explain what a HIPAA breach is, who can be involved, how to resolve it, and what must be done. 

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCJA017
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 Duration: 60 mins

Conducting Effective Compliance Investigation Interviews.

This presentation will give attendees a blueprint for conducting effective compliance investigation interviews.  Given that responding to detected offenses are included in the Seven Elements of an Effective Compliance Program as deemed by the Office of Inspector General ("OIG"), this webinar is intended to provide helpful strategies for conducting and documenting investigation interviews.  To help guide the discussion, Mr. Anstine will ........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCP009
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 Duration: 60 mins

Writing Effective Compliance Documentation.

Compliance documentation to include Standard Operating Procedures - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regu........

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 Webinar Id: LSHCTG001
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 Duration: 60 mins

Assay Validation for Clinical Diagnostics

This webinar will cover what is necessary for the validation of an assay in a clinical diagnostics setting

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 Webinar Id: LSHCTMBI004
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 Duration: 60 mins

The Revised Total Coliform Rule (RTCR)

Total coliforms are a group of related bacteria that are (with few exceptions) not harmful to humans, but are found in human waste (sewage). A variety of microbial pathogens in sewage can potentially cause health problems if humans ingest them. EPA no longer considers enumeration of total coliforms a useful indicator of other pathogens for drinking water. Total coliforms are used to determine the adequacy of water treatment and the inte........

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 Webinar Id: HIPMRB002
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 Duration: 60 mins

HIPAA and the administrative subpoena ? how HIPAA does or does not protect you when the government comes calling for your patient records and you are in trouble

This webinar reviews core privacy requirements of HIPAA then covers in detail the ways state licensure boards and agencies use the authority of state law to cover HIPAA exceptions and gain access to your patient records. What authority exists in state law to do so? How does that mesh with the federal law requirements and privacy mandates of HIPAA? What do you do when the government comes calling for protected health information on your ........

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 Webinar Id: LSHCDLT001
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 Duration: 90 mins

Why your Organization Needs ISO 45001 and Understanding the Updated Concepts as Compared to Other Safety & Health Management Systems

Workplace incidents impact not only your employees but also result in a significant drain on the bottom line. Most companies today have turned to homegrown programs or standard frameworks like OHSAS 18001 to deal with these issues. Today, gain an understanding of how the new and updated concepts in ISO 45001 can have an impact on legal requirements, operational controls, risks, opportunities & performance and progress towards your compa........

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 Webinar Id: LSHCBJA015
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 Duration: 60 mins

Breach Notification Rule: A Blueprint for Conducting Consistent Risk Assessments.

This presentation will provide a blueprint for consistently conducting risk assessments under the HIPAA Breach Notification Rule. More specifically, it will address topics such as what constitutes a breach, what to include in a Breach Notification policy, how to conduct a risk assessment analysing any issue, and how to document your risk assessment. This presentation will use a situational examples that attendees can relate to in order ........

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 Webinar Id: HIPSFD001
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 Duration: 90 mins

FMLA, ADA, USERRA, Workers Compensation, and HIPAA: Navigating the Bermuda Triangle of Medical Leaves

Understanding the basics of, as well as the similarities, the distinctions, and the interrelationships among the Family Medical Leave Act (FMLA), the Americans with Disability Act (ADA), workers' compensation laws, the Uniformed Services Employment and Reemployment Rights Act (USERRA), and the Health Insurance Portability and Accountability Act (HIPAA) is critical to your business.

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 Webinar Id: HIPUAP001
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 Duration: 60 mins

Encryption & HIPAA Mandates

Firewall systems are the first line of defense. Encryption and HIPAA mandates are the last line of defense. In between the two lines of defense, businesses deploy a multitude of security controls to prevent unauthorized access and tenacious attacks. Firewall systems are the first line of defense. Encryption is the last line of defense. In between the two lines of defense, businesses deploy a multitude of security controls to prevent una........

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 Webinar Id: HIPJPT001
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 Duration: 60 mins

How to do a HIPAA risk analysis

After explaining the need for conducting a HIPAA risk analysis and the penalties for not doing so, this Webinar will provide attendees a methodology for doing so. HIPAA does not specify a particular way of conducting such an analysis. But the author has taken hundreds of covered entities and business associates through the process and his way of doing must work because none of them have had a security breach.

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 Webinar Id: LSHCWJL002
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 Duration: 90 mins

What Employers Need to Know about Medical Marijuana In the Workplace

Most recent laws legalizing marijuana use have been geared towards removing criminal penalties for users, and do not fully address workplace issues posed by medical marijuana. Some state laws explicitly prohibit employers from discriminating against employees because of their status of medical marijuana cardholders. Some may only addresses the impact of a positive drug test for a limited set of job duties, such as public utility workers........

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 Webinar Id: LSHCCP005
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 Duration: 60 mins

Classifying Medical Devices

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination process, how you apply the classification pr........

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 Webinar Id: LSHCIMBI004
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 Duration: 60 mins

Is it Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Although method validation and method verification are related terms, they have very different analytical and statistical req........

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 Webinar Id: HIPHTS001
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 Duration: 60 mins

HIPAA: HIGHLIGHTS HOOPLA and HOOEY

Buying a fill-in- the-blank template does not equal HIPAA compliance, and doing nothing, or saying "I didn't know" can result in willful negligence. Translation: Fines that start at $10,000 and go up exponentially for each violation. I teach healthcare practices who want to be HIPAA compliant, but don't want the time consuming frustration or risk that comes with not knowing the process.

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 Webinar Id: LSHCMPH005
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 Duration: 60 mins

MACRA & MIPS - Patient Engagement - HIPAA Rules for Text Messaging & Email

There are widespread violations of the HIPAA Rules for communicating with patients by unencrypted email and text message - largely because Providers and Business Associates just don't know the rules - and don't understand what PHI really is - as defined by HIPAA. The HIPAA Rules and HHS/OCR guidance provide a simple, easy to use 3 Step Safe Harbor for using unencrypted email and text messaging to engage patients. This session will expla........

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 Webinar Id: LSHCNJA020
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 Duration: 60 mins

Navigating the Politics of Healthcare from the Compliance Role

This presentation will cover four main strategies the compliance professional can use to navigate the politics of healthcare to obtain buy-in to the compliance program. Additionally, the presentation will include strategies for improved communications with physicians and healthcare leaders.  

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 Webinar Id: HIPBLT006
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 Duration: 60 mins

New HIPAA Regulations Affect Business Associates: That was then, this is now.

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. Times have changed and unfortunately many businesses are losing clients or unab........

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 Webinar Id: HIPMRB001
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 Duration: 60 mins

HIPAA privacy exceptions for law enforcement purposes as applied to health care professionals

This webinar starts with a review of the core requirements of HIPAA then covers in detail the many exceptions that apply to law enforcement purposes as applied to health care professionals. What do you do when the police come calling for protected health information on your patient? And because the patient is in trouble? Or because you are in trouble? Gain a firm understanding of the HIPAA exceptions for law enforcement purposes.

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 Webinar Id: LSHCGRG002
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 Duration: 60 mins

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a giv........

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 Webinar Id: LSHCCJA016
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 Duration: 60 mins

Compliance with the CMS Physician Open Payments Rule.

Open Payments is a federal program under the Centers for Medicare and Medicaid Services ("CMS") that collects certain information relating to payments and other items of value provided to physicians from drug and device companies. Examples include: speaking fees, gifts, meals, and covering the cost of travel expenses to name a few. The Open Payments program also includes information on ownership interests a physician may have in a drug ........

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 Webinar Id: HIPHSSK001
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 Duration: 60 mins

Navigating HIPAA/HITECH Regulatory Compliance Strategies.

As the compliance deadline for new HIPAA-HITECH rule approaches, it becomes imperative for healthcare business associate organizations to develop strategies to protect electronic health information, and comply with HIPAA-HITECH regulations. This instructor-led one-day training will teach you how to design, implement, and administer comprehensive healthcare IT compliance and security protection programs as a business associate. During th........

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 Webinar Id: LSHCTG002
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 Duration: 60 mins

Translating Academic and Discovery Assays Into GLP Compliant Assays

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCP007
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 Duration: 60 mins

Training in Regulated Environments

Training is the process by which individuals acquire skill and knowledge. There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness. Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training. Read and Understand is a technique that is and has been ........

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 Webinar Id: LSHCUJR001
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 Duration: 90 mins

Using Your Food Safety Data to Drive Cost Reductions and Process Improvements

In today's world of food safety, everyone in the supply chain is challenged to document what they are doing. This seemingly expensive documentation yields data that is valuable to cutting costs, improving food safety, meeting legal requirements and improving business processes. But most companies do not yet know how to use the data they spend so much time and money collecting. Yet, there are some relatively easy, quick to implement anal........

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 Webinar Id: HIPBLT007
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 Duration: 60 mins

Understanding The New HIPAA Risk Audit - Are You Fully Prepared?

HIPAA NOW HAS TEETH! It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for covered entities. This once relatively benign legislation is being fully enforced and the news is not good for covered entities or business associates! Be prepared! Protect your practice or business! What factors might spurn a HIPAA audit? ...are you doing these things? Why are the Feds enfor........

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 Webinar Id: LSHCHJA023
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 Duration: 60 mins

Preparing the front office staff to carry out HIPAA privacy procedures.

HIPAA audits are on the rise, and you'll probably be surprised to learn that you are most likely to be targeted for a HIPAA audit based on a patient compliant. And your front desk could be a target area. And not always for the reasons you'd think. HIPAA compliance makes your front-desk staff more important than ever. How they handle their everyday tasks and interact with your patients can not only cause you to get audited, but can also ........

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 Webinar Id: LSHCJAT001
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 Duration: 60 mins

Transition to ISO 13485:2016

This course will provide an overview of the differences between the 2016 version of ISO 13485 compared to the existing version, and how to transition to the standard. 

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 Webinar Id: HIPBLT001
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 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Audits - An Insiders Perspective

Brian will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (Brian been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This lesson will be addressing ho........

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 Webinar Id: LHSCDRD001
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 Duration: 60 mins

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to........

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 Webinar Id: LSHCHJ004
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 Duration: 60 mins

The Requirements & Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance.  This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facili........

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 Webinar Id: LSHCMRB001
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 Duration: 60 mins

Health Care Investigations by the Government - How They Do It.

State government agencies tasked with investigating alleged misconduct in health care generally follow proscribed steps in investigating the misconduct. This can include agencies with authority over individually licensed health care practitioners or with authority over the administration of government health care programs - whose budgets are in the hundreds of millions of dollars. Gathering (and even seizing) evidence and interviewing w........

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 Webinar Id: LSHCCJA012
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 Duration: 60 mins

Clear, Complete, and Concise: Strategies for Writing an Investigation Report

This webinar provides a blueprint for how to effectively draft a compliance investigation report. Given the frequent occurrence that compliance officers find themselves in with having to respond to identified issues through an investigation, this presentation is intended to help attendees apply a consistent approach for drafting an investigation report that can be defended. Mr. Anstine will walk attendees through a sample fact pattern t........

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 Webinar Id: LSHCLSH005
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 Duration: 75 mins

Best Practices in Nursing Documentation: Writing Effective and Legal Proof Notes

This healthcare documentation webinar will discuss how to create a lawsuit-proof, auditable nursing documentation and how to maintain compliance over the course of the document life-time. You will learn how to de-risk your documentation so as to withstand legal scrutiny. Documentation is the backbone of Medical Necessity and support for services provided. Understanding what is required for documentation is essential. Inappropriate docum........

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 Webinar Id: LSHCSCP003
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 Duration: 60 mins

Sterilization of Pharmaceutical Products and Medical Devices

This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considere........

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 Webinar Id: LSHCHPH003
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 Duration: 60 mins

HIPAA - 7 Deadly Sins - 7 Simple Solutions

Top 7 HIPAA Violation Concerns revealed by Federal HIPAA Compliance Audits ordered by Congress. The U. S. Department of Health and Human Services (HHS) is conducting mandatory HIPAA Compliance Audits of covered entities and business associates to ensure they comply with HIPAA Privacy and Security Law. HHS's HIPAA Compliance Audit has more than 170 detailed sections - but picked only 7 for the first round! Why? Those 7 are responsible fo........

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 Webinar Id: LSHCHEW003
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 Duration: 60 mins

How to Conduct a Human Factors/ Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

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 Webinar Id: LSHCGJS002
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 Duration: 60 mins

Strategies for billing medicare for durable medical equipment -from getting DME PTAN# to full accreditation

Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines. Then learn how to get fully Accredited that can grow your business dramatically!!  Key strategies of a successful program Understa........

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 Webinar Id: LSHCSJM003
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 Duration: 90 mins

Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Utilizing suppliers as an extension of an organization's design and manufacturing capabilities presents unique challenges.

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 Webinar Id: HIPBLT003
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 Duration: 60 mins

Preparing for Imminent Federal HIPAA Audits.

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

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 Webinar Id: LSHCMRB003
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 Duration: 60 mins

Beyond HIPAA: Patient Medical Records and Client Confidentiality in Mental Health

State law and contractual requirements mandate medical record keeping compliance. Then, compliance with HIPAA for protected health information in those records intersects with state laws and codes of ethics which mandate confidentiality, but there are many state law exceptions recognized by HIPAA. The exceptions sometimes allow and sometimes mandate what would otherwise be a confidentiality breach. The sanctity of the doctor-patient rel........

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 Webinar Id: LSHCMBI003
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 Duration: 60 mins

ISO/ IEC 17025:2017 Update: Everything Old is New Again

Many laboratories have successfully developed and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Some are still struggling to get accredited and even those already accredited still have issues as evidenced by the number of non-conformances cited during the subsequent biannual audits. Have the rules changed? What a........

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 Webinar Id: LSHCRD001
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 Duration: 60 mins

Use of Electronic Health Record Data (EHR) in FDA-regulated clinical investigations

This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

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 Webinar Id: LSHCHGJS001
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 Duration: 60 mins

How To Bill Medicare for Durable Medical Equipment and Stay Legal Compliant

Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines. This webinar will walk you through the process of how to do the following: How to get a Medicare DME PTAN # Understanding the Anti-Kickba........

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 Webinar Id: HIPBLT005
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 Duration: 90 mins

HIPAA for Dummies (HIPAA Boot Camp)

This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will al........

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 Webinar Id:  LSHCJA011
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 Duration: 90 mins

Monitoring and Investigating Drug Diversion

This webinar will walk attendees through monitoring against drug diversion and investigating alleged diversions. More specifically, it will discuss the warning signs of diversion, common methods used to carry out diversion, potential organizational vulnerabilities, investigating a diversion case from beginning to end, and offer tips for safeguarding against diversion. To help highlight certain discussion points, Mr. Anstine will additio........

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 Webinar Id: LSHCHEW002
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 Duration: 60 mins

Human Factors/ Usability following ISO 62366 and new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the........

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 Webinar Id: LSHCGCP002
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 Duration: 60 mins

GMP Auditing for Pharmaceutical Manufacturing

Auditing involves a comprehensive review of vendors that will provide resources and/or services. The ICH Q10 document provides an outline on the pharmaceutical drug product life-cycle. Through the review of ICH Q8, Q9, and Q10, the participant will be able to audit the various activities associated with the different stages of the product lifecycle. By using a scientific risk-based approach, as outlined in ICH Q9, the participant will b........

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 Webinar Id: LSHCIPH002
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 Duration: 60 mins

New HIPAA Rules for Communicating with Patients by Unencrypted Email and Text Messages

Communicating with patients by unencrypted email and text message (SMS) about a variety of topics (appointment reminders, patient satisfaction, etc.) is growing dramatically. The HIPAA Rules for sending Protected Health Information (PHI) by electronic messages have been clarified. But most Providers and Business Associates are not following the HIPAA Rules. Email and text message are subject to the HIPAA Security Rule transmission stand........

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 Webinar Id: HIPBLT004
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 Duration: 60 mins

HIPAA Audits - An Insiders Perspective

Speaker will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (He has been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. This lesson will be addressin........

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 Webinar Id: LSHCMRB002
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 Duration: 60 mins

Evidence-Based Dentistry - A New Standard for Disciplinary Actions.

Learn to identify, understand, and defend against new legal standards in dentistry that may apply to state licensure disciplinary actions and to civil claims for malpractice. Either claim may result in ruinous practice and career consequences for the health care professional held to an objective standard of care for dentists. "Unprofessional conduct" and "negligence" are legal standards applicable to the standard of care to be met by a ........

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 Webinar Id: LSHCHJK004
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 Duration: 60 mins

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Al........

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 Webinar Id: LSHCRD002
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 Duration: 90 mins

FDA Regulation, 3D Printing and Medical Devices

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCAWMC002
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 Duration: 120 mins

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: HIPBLT002
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 Duration: 60 mins

HIPAA and Personal Devices (myths vs realities)

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LHSCTJA016
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 Duration: 60 mins

Tracking Physician Gifts Under The Stark Non-Monetary Compensation Rule.

The Stark law generally prohibits physicians from referring Medicare patients for designated health services ("DHS") to an entity the physician or immediate family member has a financial relationship with, unless an exception applies. Under Stark, there is an exception known as the Non-Monetary Compensation ("NMC")exception (42 C.F.R. 411.357(k) that allows DHS entities that are the recipient of Medicare DHS referrals to provide certain........

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 Webinar Id: LSHCEW002
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 Duration: 60 mins

How to Prepare a FDA 510(k) submission

we will explain what a 510(k) is and the procedure to prepare the submission. the several types of 510(k) will be explained.Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. we will cover the requirements for software.

$237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCACP001
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 Duration: 60 mins

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There........

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 Webinar Id: LSHCFJM003
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 Duration: 90 mins

FDA Inspections : What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

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 Webinar Id: LSHCTJM001
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 Duration: 90 mins

Technical Writing for the Pharma, Biologics, and Medical Device Industry

This course addresses how to write effective correspondence ,reports, SOPs, and protocols in support of your company's activities.

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 Webinar Id: LSHCCP004
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 Duration: 60 mins

Building a Compliant Documentation & Training System

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing within regulated industries - foods, cosmetics, beverages, medical devices, pharmaceuticals, biologics, etc. Yet, training is equally as important as any compliance discipline. The maj........

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 Webinar Id: LSHCRPH001
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 Duration: 60 mins

Ransomware and HIPAA - How to Prevent, Prepare, Respond, Recover

This course explains treacherous Ransomware threats attacking the Healthcare Industry and how to prevent, prepare for, respond to and recover from a Ransomware attack. It covers HIPAA Rules that apply to Ransomware, compliance with the HIPAA Rules and how to conduct a HIPAA Breach Risk Assessment to prove a Ransomware attack did not result in a Breach of Unsecured Protected Health Information (PHI) - a violation of the HIPAA Privacy Rul........

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 Webinar Id: LSHCBT008
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 Duration: 90 mins

HIPAA Enforcement - A Myths or Reality?

This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as ........

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 Webinar Id: HIPHLH001
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 Duration: 75 mins

HIPAA Internal Audit Process & Policies: Your 1st Line of Defence

This course covers the components of an internal Audit process for HIPAA compliance. Why the audit is needed to support HIPAA compliance.What records are needed to ensure that your audit is replicable and supports your findings. Audits aspects which are crucial to ensure compliance,but can be part of your daily activities ; reducing time and man hours needed. Why auditing needs to be ongoing and not just occurring "when needed" or prior........

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 Webinar Id: LSHCENK005
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 Duration: 60 mins

Emergency Medical Treatment and Active Labour Act (EMTALA)

This webinar will examine the complexities and simplicities of EMTALA, the Emergency Medical Treatment and Active Labor Act. The webinar will distill the requirements of law, including its non-intuitive, highly-detailed definitions. The webinar will also discuss best practices for compliance and practical tips for compliance with the challenging situation of managing patients with psychiatric emergency medical conditions.

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 Webinar Id: LSHCEJK003
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 Duration: 60 mins

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well a........

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 Webinar Id: LSHCHJ003
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 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy and Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

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 Webinar Id: LSHCMBI002
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 Duration: 60 mins

Is it Method Verification or Validation, or Just Semantics

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Although method validation and method verification are related terms, they have very different analytical and statistical req........

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 Webinar Id: LSHCCEW001
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 Duration: 60 mins

21 CFR part 11 Compliance - electronic records & electronic signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records f........

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 Webinar Id: LSHCHNK004
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 Duration: 60 mins

HIPAA And Litigation-Getting and Producing Records Through Discovery

This webinar will examine the interplay between HIPAA and state law when it comes to requesting and producing health records in the context of litigation. The webinar will address how attorneys should properly request health records and how covered entities and business associates should properly respond to such requests.

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 Webinar Id: LSHCSRC001
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 Duration: 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product.  Proper understanding and testing of the sterile filtration system accordin........

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 Webinar Id: LSHCBT003
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 Duration: 180 mins

3-Hour Virtual Seminar on HIPAA Phase 2 Audits: How to be Prepared - An Insider's Perspective

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).  It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received  This lesson will be addressing how p........

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 Webinar Id: LSHCHTS002
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 Duration: 60 mins

HIPAA: HIGHLIGHTS HOOPLA & HOOEY

Putting together a comprehensive HIPAA protocol and policyprogram can be a daunting task. In his course, learn the required changes to the Notice of Privacy Practices Form, the financial implications for willful neglect, why a daily data backup is no longer enough, and the communications that must not be sent via email or text. Gain a better understanding of the steps required to achieve compliance and protect both patients and the prac........

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 Webinar Id: LSHCMBI001
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 Duration: 60 mins

ISO/IEC 17025:2017 Update: Everything Old is New Again

Many laboratories have successfully developed and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Some are still struggling to get accredited and even those already accredited still have issues as evidenced by the number of non-conformances cited during the subsequent biannual audits. Have the rules changed? What a........

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 Webinar Id: LSHCHNK003
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 Duration: 60 mins

HIPAA Compliance in Light of Recent Enforcement Actions

This webinar will examine recent HIPAA enforcement actions and trends and will discuss practical insights on HIPAA from such enforcement activities. The webinar will cover HIPAA hot topics, as reflected in enforcement actions, and will provide guidance on avoiding enforcement actions.

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 Webinar Id: LSHCJPT004
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 Duration: 60 mins

What are Reasonable and Appropriate HIPAA Security Measures?

Often healthcare and related businesses do not understand that HIPAA is far more about policies and procedures than it is about technical security measures. The HIPAA Security Rule, for example, does not specify whether an entity must have a password system and, if it does, how many characters it must have and whether it has to be alphanumerical with one or more special characters or whether it must have some type of biometric identific........

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 Webinar Id: LSHCBT007
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 Duration: 90 mins

Why Should be Worried About HIPAA? All You Need to Know.

The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. Times have changed and unfortunately many businesses are losing clients or unab........

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 Webinar Id: LSHCBT006
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 Duration: 90 mins

How to conduct a HIPAA Security Risk Assessment and Write Policies?

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated ........

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 Webinar Id: LSHCJA010
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 Duration: 60 mins

Auditing for EMTALA Compliance

This webinar is designed to walk attendees through a process for auditing your organization's compliance with The Emergency Medical Treatment And Labor Act ("EMTALA"). More specifically, it will provide an overview of EMTALA, discuss key compliance challenges facing organizations who must comply, and discuss a step-by-step approach for routine and periodic auditing.

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 Webinar Id: LSHCCP003
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 Duration: 60 mins

Writing Effective Compliance Documentation

Compliance documentation to include Standard Operating Procedures - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regu........

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 Webinar Id: LSHCBJK002
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 Duration: 60 mins

Best Practices in Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a Lean, Cost-effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.  Most medical device manufacturers have acceptable systems in place to assure component quality. B........

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 Webinar Id: LSHCSBT001
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 Duration: 90 mins

Spotting a Weasel: The Personality of Dental Embezzler - 18 RED FLAGS!

Embezzler's view dental practices as "easy pickings" and have more time to work their schemes than doctors do to provide the management oversight they must today! After all, embezzlement is deception of exploiting vulnerabilities and coming up with schemes only limited by the weasel's imagination.

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 Webinar Id: LSHCHJ002
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 Duration: 60 mins

The Roles And Responsibilities of a HIPAA Privacy & Security Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

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 Webinar Id: LSHCBT009
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 Duration: 90 mins

HIPAA Changes 2017

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

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 Webinar Id: LSHCJPT003
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 Duration: 60 mins

How to Perform a HIPAA Risk Analysis

Risk analysis is the key to implementing reasonable cost-effective security measures. And failure to conduct and update risk analyses are the single biggest cause of Health and Human Services imposed civil money penalties of up to several million dollars. And failure to conduct one has other affects as well-remediation and mitigation (lessening the harm of) costs, bad publicity, lost business and the like.

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 Webinar Id: LSHCJA009
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 Duration: 60 mins

Telemedicine: Navigating Through Key Compliance Challenges

This webinar is designed to provide an overview of the common compliance challenges to delivering healthcare through telemedicine and offer strategies to ensure compliance. More specifically, Mr. Anstine will discuss issues such as state licensure, credentialing & privileging, liability insurance, reimbursement, establishing a physician-patient relationship, patient confidentiality, and online prescribing. In addition to walking through........

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 Webinar Id: LSHCLSH004
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 Duration: 90 mins

HIPAA Audits - Phase 2 What does this mean for you ?

The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. Will look at the process and whom it applies to. What the audits will focus on. Risk assessment will be reviewed and why this is important for your organization. Need to identify Key personnel for oversight of the focus areas. Information related to your business associates that is needed and can ........

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 Webinar Id: LSHCJPT002
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 Duration: 60 mins

How to Write and Adopt HIPAA Policies and Procedures

Often healthcare and related businesses do not understand that HIPAA is far more about policies and procedures than it is about technical security measures. The HIPAA Security Rule, for example, does not specify whether an entity must have a password system and, if it does, how many characters it must have and whether it has to be alphanumerical with one or more special characters or whether it must have some type of biometric identific........

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 Webinar Id: LSHCHNK002
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 Duration: 60 mins

HIPAA For Employee Benefits Teams

This webinar will provide practical insights on HIPAA, including its applicability, its general rules, and requirements for compliance as it relates to employee benefits plans for companies, regardless of specific industry.

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 Webinar Id: LSHCJA013
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 Duration: 180 mins

3-HR VIRTUAL SEMINAR ON Beyond the Allegation: How to Effectively Conduct Compliance Investigations.

This webinar will give attendees a blueprint for conducting effective compliance investigations, from A-Z. Given that responding to detected offenses are included in the Seven Elements of an Effective Compliance Program as deemed by the Office of Inspector General ("OIG"), this presentation is intended to provide strategies and tips for conducting and documenting investigations in a manner that can be defended should a complaint be made........

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 Webinar Id: LSHCCP001
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 Duration: 60 mins

Managing for Compliance Effectiveness

Conforming to regulatory requirements, following all of the rules, and ensuring regulatory compliance is in no small part within the ability of the workforce to execute but in order to do this, the workforce must know what to do, how to do it, have the personal capacity to do it, have the tools to do it, and must be motivated to do it. Performance management is not about conducting yearly performance reviews - it is about knowing how pe........

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 Webinar Id: LSHCJPT001
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 Duration: 60 mins

How to Handle HIPAA and HITECH Act Breaches, Complaints, and Investigations: Everything You Need to Know

This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also consti........

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 Webinar Id: LSHCML002
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 Duration: 75 mins

FDA GMP Requirements for API (Active Pharmaceutical Ingredients) - Just what do YOU need to do?

While this topic may appear easily addressed, appearances can be deceiving. This program will examine some history, real life experiences and discuss the real facts about GMP for Active Pharmaceutical ingredients. Just what is important to firms, producers of API and consumers of API. Discussed will be what regulations apply and what guidance is important. Also examined are various ICH and FDA guidance that enter the everyday business o........

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 Webinar Id: LSHCJME003
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 Duration: 90 mins

Validation and Part 11 Compliance

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies o........

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 Webinar Id: LSHCHNK001
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 Duration: 60 mins

HIPAA Basics for Non-Healthcare People

This webinar will provide a broad overview of HIPAA, including its applicability, its general rules, and requirements for compliance.

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 Webinar Id: LSHCBJK001
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 Duration: 60 mins

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quali........

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 Webinar Id: LSHCJM0001
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 Duration: 90 mins

FDA Inspections: What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

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 Webinar Id: LSHCBT004
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 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON How to conduct a HIPAA Security Risk Assessment

This course will cover the proper methodologies on conducting a HIPAA Risk Assessment based on the formula used by Federal auditors and via the guidelines of the NIST (National Institute of Standard for Technologies). The course will also cover the most important aspects to be aware of in terms of the Federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.

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 Webinar Id: LSHCLSH003
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 Duration: 180 mins

3-hour Virtual Seminar on OIG Work Plan 2017: Trends, Reports and Issues

Every year the OIG updates what it's focus is for the upcoming year. During this session we will look at the focus for OIG audits and oversight for 2017. These work plans often drive the audits that then occur within our work sites. They provided information that is beneficial for organizations in their striving to be compliant with new regulations.

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 Webinar Id: LSHCBT001
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 Duration: 180 mins

3-hour Virtual Seminar On HIPAA Changes Under Omnibus

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

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 Webinar Id: LSHCJA014
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 Duration: 180 mins

3-hr Virtual Seminar on Compliance 101: Tackling the Common Realities You Will Encounter in the Profession.

This webinar will walk attendees through the most common political dilemmas facing any healthcare compliance professional on a daily basis no matter where they work in healthcare. In addition to identifying these common realities, Mr. Anstine will provide strategies, insights, and tips for how to overcome each reality in order to succeed in the role.  

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 Webinar Id: LSHCDD001
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 Duration: 60 mins

Achieving Success and Compliance in the Supply Chain

supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities involve the transformation of natural resources, raw materials, and components into a finished product that is delivered to the end customer.

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 Webinar Id: LSHCJMAA002
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 Duration: 90 mins

An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.

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 Webinar Id: LSHCBT005
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 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON Ransomware and HIPAA - Be very careful here!

I will be speaking to real life situations I have personally dealt with on multiple occasions as part of HIPAA investigations relating to ransomware breaches. These can be absolutely devastating to your practice or business and can cause a major financial burden as well as embarrassment. I will give specific information regarding multiple incidents and what they practice/business did wrong and how these situations occurred - there are m........

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 Webinar Id: LSHCKO001
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 Duration: 60 mins

HIPAA for Medical and Dental Practices

This webinar covers privacy and security training for employees of private medical and dental practices and their business associates. The primary purpose is to fulfill HPAA's requirement for employee training and to improve HIPAA compliance.

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 Webinar Id: LSHCKO002
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 Duration: 60 mins

OSHA for Medical and Dental Practices

This webinar covers safety and health hazards typically found in private medical and dental practices. The primary purpose is to fulfill OSHA's requirement for employee training.

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 Webinar Id: LSHC003
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 Duration: 60 mins

Workplace Shootings: What You Need to Know Before, During, and After

In this online session, Joe Rosner, a nationally recognized expert on workplace violence and personal safety, you will gain insights in assessing and mitigating the risks of violence in the workplace. You'll learn the Who, What, Where and Why of workplace shooters. You will also learn why having plans, policies and procedures can greatly reduce the chances of an active shooter at your facility.

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 Webinar Id: LSHCJM004
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 Duration: 90 mins

ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2015 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing proce........

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 Webinar Id: LSHCNP001
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 Duration: 60 mins

Investigator initiated trials- What are we doing to ensure human subject protection?

This 1-hr virtual seminar will help you understand the key issues and challenges associated with investigator initiated trials. Investigator initiated trials are very important as they are important connection for the translation of research from bench to bedside. I will discuss the role of sponsor-investigator and ways we can ensure the protection of human subjects in an investigator initiated trials. 

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 Webinar Id: LSHCJA007
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 Duration: 60 mins

Looking Inward: Assessing the Effectiveness of Your Compliance Program

This webinar is designed to walk attendees through a self-assessment of the effectiveness of his/her compliance program to determine if the program is meeting the Federal government's standards (e.g. The Office of Inspector General's "Seven Elements of an Effective Compliance Program"). More specifically, this presentation will walk through a checklist of questions directed at each of the seven elements and offer strategies and tips for........

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 Webinar Id: LSHCHJ001
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 Duration: 60 mins

The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facilit........

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 Webinar Id: LSHCJM002
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 Duration: 90 mins

Process Validation for Pharma and Biologics Industries

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how to develop rigorous protocols and reports, as ........

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 Webinar Id: LSHCJA006
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 Duration: 60 mins

Compliance Program Infrastructure: The Basics Needed to Launch Your Compliance Program

This webinar is designed to provide an overview of the core infrastructure needed to launch a healthcare compliance program. More specifically, it will provide an overview of the Seven Elements of an Effective Compliance Program as deemed by the Federal government, and interpret what each element means to your program on a daily basis. Additionally, this presentation will offer strategies and tips for getting your infrastructure in plac........

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 Webinar Id: LSHCSS002
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 Duration: 90 mins

Inclusion of LGBT Employees in Healthcare: Navigating Policies, Procedures, and Practices

Healthcare is a unique culture dealing with vulnerable patients and employees committed to quality patient care. However, research states that LGBT patients are treated in a more abusive manner than straight patients. How does the misconduct to LGBT patients impact your LGBT employees? We know that healthcare does employ LGBT people. How does your organization ensure they are welcome? Do you intentionally recruit the LGBT community as e........

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 Webinar Id: LSHCML001
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 Duration: 75 mins

Outsourcing and/or Purchasing API or Excipients - An Examination of Quality/Business Issues you should consider!

This program examines considerations that are important to firms that are considering if they should produce, outsource, or purchase API. The steps discussed during this program also have application to Excipients that are used by drug product producers. The subject has both Quality and Business implications which are important to a corporate plan's success. It discusses risks and benefits associated with these decisions and what a plan........

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 Webinar Id: LSHCSK0012
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 Duration: 60 mins

HOW TO MANAGE OCR/HHS HIPAA/HITECH AUDIT

Among other things, the HITECH Act significantly strengthened HIPAA enforcement activities. In addition to increasing penalties, allowing enforcement by state attorneys general, requiring notices of breaches, and making business associates directly subject to penalties, the HITECH Act mandated that Office for Civil Rights of HHS conduct HIPAA audits. This one-hour webinar will focus on preparation required by healthcare organizations to........

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 Webinar Id: LSHCBT002
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 Duration: 180 mins

3-HOUR VIRTUAL SEMINAR ON HIPAA: Upcoming Changes for 2017

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak o........

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 Webinar Id: LSHCSK001
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 Duration: 60 mins

HIPAA/HITECH ASSESSMENT FOR HEALTHCARE BUSINESS ASSOCIATES

As the compliance deadline for new HIPAA-HITECH rule approaches, it becomes imperative for healthcare business associate organizations to develop strategies to protect electronic health information, and comply with HIPAA-HITECH regulations. This instructor-led one-day training will teach you how to design, implement, and administer comprehensive healthcare IT compliance and security protection programs as a business associate. During th........

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 Webinar Id: LSHCSS001
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 Duration: 90 mins

A New Civil Rights Law for Health Providers, Employees of Health Programs, and Health Insurance Companies: Section 1557 of the Affordable Care Act

Healthcare providers such as hospitals, clinics, physicians, community health centers, nursing homes, home care agencies, health insurance companies (including those found in the Health Insurance Marketplaces), and any other "covered entities" which operate a "health program or activity" have a new civil rights law to incorporate into their operations. The Department of Health and Human Services (HHS) recently issued its final rule to d........

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 Webinar Id: LSHCJM001
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 Duration: 60 mins

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment........

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 Webinar Id: LSHCPJB001
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 Duration: 90 mins

Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes a........

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 Webinar Id: LSHCLSH002
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 Duration: 75 mins

HIPAA Internal Audit Process and Policies: Your 1st Line of Defence

This course covers the components of an internal Audit process for HIPAA compliance. Why the audit is needed to support HIPAA compliance.What records are needed to ensure that your audit is replicable and supports your findings. Audits aspects which are crucial to ensure compliance,but can be part of your daily activities ; reducing time and man hours needed. Why auditing needs to be ongoing and not just occurring "when needed" or prior........

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 Webinar Id: LSHCJA005
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 Duration: 60 mins

Your First 100 Days as a Compliance Officer: Strategies to Prioritize Your Workload.

This webinar is designed to provide a realistic overview of what your first 100 days on the job as new compliance officer should look for any healthcare organization. It will discuss how to effectively on board to the organization and prioritize your workload for the first 100 days and beyond.

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 Webinar Id: FSPV003
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 Duration: 90 mins

Writing High-Profile Project Evaluation Reports

The reality of any professional discipline is this: If it is not in writing, it never happened. All the professional observation and objective review that a clinician puts into an analysis are meaningless unless the work appears in a complete, objective clear, and concise evaluation report. Knowing this truth is obvious; getting there is the challenge.

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 Webinar Id: LSHCCPA001
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 Duration: 60 mins

Environmental Monitoring - Knowing your Cleanroom

This webinar will provide the proper methods and techniques required to maintain a clean room per FDA and ISO regulations. By the use of viable and non-viable testing, a cleanroom can be maintained. The results collected can determine the state of control the cleanroom operates on a continuous basis. In order to maintain a cleanroom, a proper cleaning agent rotation needs to be implemented. The webinar will provide a discussion of the m........

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 Webinar Id: LSHCWMC001
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 Duration: 60 mins

The Health Care Quality Improvement Act: How to Achieve Immunity

This webinar will discuss the Health Care Quality Improvement Act (HCQIA or the Act) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the Act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the Act. Next will be a review of the standards und........

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 Webinar Id: LSHCPJB002
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 Duration: 90 mins

SOP compliance management: A must for the pharmaceutical industry.

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

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 Webinar Id: LSHCNP002
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 Duration: 60 mins

Ethical Requirements & Development of Guidelines for Pediatric Trials in Developing Countries

This 1-hr virtual seminar will help you understand the key ethical issues and challenges associated with pediatric studies in developing countries. Pediatric populations in developing countries are extremely vulnerable participants in clinical research. I will discuss some of the key ethical issues and challenges associated with pediatric studies in developing countries and suggest how these can be addressed.

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 Webinar Id: LSHCJA004
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 Duration: 60 mins

Compliance Challenges with Legalized Marijuana

This webinar is designed to provide an overview of the common challenges healthcare compliance officers must face in a world of legalized marijuana. More specifically, this presentation will begin with a brief summary of the regulatory history of marijuana in the United States and a survey of the states that have currently legalized marijuana for recreational purposes. The remainder of the presentation will focus on common compliance ch........

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 Webinar Id: LSHCJM00113
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 Duration: 60 mins

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principl........

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 Webinar Id: LSHCEW001
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 Duration: 60 mins

Hazard Analysis following ISO 14971

Designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data that the majority of recalls were due to a faulty design process. These recalled products were tested before release and later found to fail in unanticipated ways that were not considered in the testing process. FDA also concluded th........

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 Webinar Id: LSHCJA012
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 Duration: 60 mins

Navigating the Compliance Challenges with Holiday Gifts

This webinar is designed to help attendees navigate through the compliance challenges related to holiday gift giving and receiving with physicians, vendors, patients, and co-workers. More specifically, it will discuss the regulatory framework surrounding gifts, common gifting scenarios, the pitfalls to avoid, and strategies for drafting organizational gift policies.

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 Webinar Id: LSHCGS002
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 Duration: 60 mins

A Legal Compliance Program When Billing Durable Medical Equipment

Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines. This webinar will walk you through the process of how to do the following: How to get a Medicare DME PTAN # Understanding the Anti-Kickba........

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 Webinar Id: LSHCCT003
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 Duration: 90 mins

FDA Compliance and Laboratory Computer System Validation

You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regul........

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 Webinar Id: LSHCCP001L
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 Duration: 90 mins

New Technologies Affecting Healthcare

This course covers the new technologies affecting healthcare. During this discussion, we will look at how IoT, data analysis and advanced AI is enhancing the outcomes of individuals as well as driving new engagement models outside of the traditional care environments. As the shifting payment models are driving from fee-for-service to paying for quality outcomes, the new technologies offer continuous engagement with those in most need of........

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 Webinar Id: LSHCLSH001
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 Duration: 60 mins

2017 Proposed Home Health PPS Rule: Pre-Payment Review and Other - Regulatory Developments

The HH PPS proposed rule is one of the several rules for calendar year 2017 that reflect a broader Administration-wide strategy to create a health care system that results in better care, smarter spending, and healthier people. Provisions in these rules are helping to move our health-care system to one that values quality over quantity and focuses on reforms such as achieving better health outcomes, preventing disease, helping patients ........

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 Webinar Id: LSHRC003
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 Duration: 60 mins

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.  Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safet........

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 Webinar Id: LSHCRC004
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 Duration: 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product. Proper understanding and testing of the sterile filtration system according........

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 Webinar Id: LSHCTF001
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 Duration: 60 mins

Federal Case Law that Out-of-Network Providers Need to Know

This presentation will explore the lawsuits brought by and against health plans and health insurers against and by out-of-network Ambulatory Surgery Centers, Hospitals and other healthcare providers affecting revenue. Cases explored will include those involving balance billing issues, recoupments, assignment of benefits (legal standing) and other issues affecting the out-of-network provider. 

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 Webinar Id: LSHCJA003
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 Duration: 60 mins

How to Effectively Consult to Physicians and Healthcare Leaders on Compliance issues.

This webinar is designed to provide strategies and insights for effectively consulting to physicians and healthcare leaders on compliance issues. It will cover how to think and act like a consultant, a consistent process for consulting and strategies for communicating with disengaged physicians and leaders to improve buy-in. Using a case scenario, this presentation will walk through the steps to consulting on a hypothetical issue and of........

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 Webinar Id: LSHCMB001
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 Duration: 90 mins

Understanding and implementing an effective laboratory Quality Management System to comply with ISO/IEC 17025

QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. Accreditation to international standards is being becoming the norm in the global analytical community. Although essentially voluntary, there are many jurisdictions that now require food and environmental laboratories to be accredited to ISO/IEC 17025 in order to participate in regulatory programs. Many laboratories struggle with developing and........

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 Webinar Id: LSHCJW003
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 Duration: 60 mins

Structuring Physician Recruitment and Non-Physician Practitioner Support Arrangements Under the New 2016 Stark Rules.

In this session Mr. Wolfe will provide a general Stark Law overview. He will also discuss best practices for auditing existing recruitment arrangements and for implementing new NPP support arrangements under the new 2016 Stark rules.CMS recently finalized a number of significant changes to the Stark Law for the 2016 calendar year, including a new Stark exception that allows hospitals to provide financial support to physician practices l........

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 Webinar Id: LSHCJA002
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 Duration: 60 mins

Clear, Complete, and Concise: Strategies for Writing an Investigation Report

This webinar provides a blueprint for how to effectively draft a compliance investigation report. Given the frequent occurrence that compliance officers find themselves in with having to respond to identified issues through an investigation, this presentation is intended to help attendees apply a consistent approach for drafting an investigation report that can be defended. Mr. Anstine will walk attendees through a sample fact pattern t........

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 Webinar Id: LSHCJF001
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 Duration: 90 mins

Making Sense of the FMLA, ADA and Workers Comp Overlap

Few employers can say they have never had challenges with leave of absence issues. Virtually every employer in every sector of the American (and global) economy has. The Family Medical Leave Act (FMLA) requires covered employers to allow eligible employees up to 12 weeks of unpaid job-protected leave and benefits to care for their own or a family member's serious health condition. The Americans with Disabilities Act (ADA) and the Americ........

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 Webinar Id: LSHRC002
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 Duration: 60 mins

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.  Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

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 Webinar Id: LSHCJA001
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 Duration: 75 mins

Compliance with Section 1557 of the Affordable Care Act: Non-discrimination

Section 1557 of the Affordable Care Act ("ACA") is the civil rights provision prohibiting discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. This new federal rule became effective on October 17, 2016. Many of the provisions in Section 1557 already exist in other longstanding federal non-discrimination rules such as the Civil Rights Act of 1964, the Age Discrimi........

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 Webinar Id: LSHCCT002
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 Duration: 90 mins

Organizational Change Management (OCM) Best Practices for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices for creating organizational change as it relates to computer systems regulated by FDA. These include, but are not limited to system implementation, testing, validation, migration, integration, upgrade and retirement.

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 Webinar Id: LSHCGS001
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 Duration: 60 mins

A Durable Medical Equipment Revenue Program Every Practice Should Have

Increased Revenue & Profit For Your Practice! Better Service & Outcomes For Your Patients! From Your Existing Patient Base! Increase Profits $3,000-$15,000 Per Month, Per Doctor 100% Legal Compliance with Stark-Act & Anti-Kickback Statue Immediate Positive Cash-Flow Convenient One-Stop Medical Shopping For Patients Improved Compliance and Clinical Outcomes  Reduce Healthcare Costs 12%-14% All Providers Are Confronting 3 Critical Issues:........

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 Webinar Id: LSHCDD004
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 Duration: 60 mins

Managing SOP Compliance per FDA Regulations

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.

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 Webinar Id: LSHCESVM001
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 Duration: 60 mins

What will happen to your practice if you continue using unspecified codes?

Short-term and long-term consequences of using unspecified codes.

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 Webinar Id: LSHCHC002
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 Duration: 180 mins

3-hr Virtual Seminar on An overview of the pharmaceutical manufacturing cycle: ICH Q7A, GMP for pharmaceutical active ingredients (PAI) and Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals

This webinar focuses on the GMP quality system of the drug manufacturing cycle beginning with ICH Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients then focusing on 21 CFR Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals. As you are aware, the very detailed Part 210-211 GMP is the gold standard for GMP quality systems. ICH Q7A is a very good example because the structure and te........

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 Webinar Id: HCLS010
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 Duration: 90 mins

CGMP Application for Design & Operation

GMP was established back in the 60's and 70's to help Drug and Medical Device companies set up systems and related employee activities to help minimize patient risks.cGMP (current Good Manufacturing Practices needed to minimize patient risk and increase the probability of profitability) regulations require a quality related operations system that establishes and maintains a manufacturing system and related monitoring and testing specifi........

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 Webinar Id: LSHC0020
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 Duration: 90 mins

HIPAA Phase 2: Keys to Surviving an Audit

HIPAA NOW HAS TEETH! Phase 2 Audits and personal patient remedies have changed the landscape! This once relatively benign legislation is being fully enforced and the news is not good for covered entities or business associates! Be prepared! Protect your practice or business! What factors might spurn a HIPAA audit? ...are you doing these things? Why are the Feds enforcing after all these years?  We will be discussing some of the changes ........

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 Webinar Id: LSHC0016
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 Duration: 75 mins

Legislative and Regulatory Enforcement Update

This session would provide a general overview of regulatory developments impacting the business of healthcare as well as trends in enforcement from the government's perspective.  It will primarily focus on fraud and abuse and patient privacy, but may also include other selected topics depending on regulatory activity in 2016.  This session will include covering key regulatory developments and walking attendees through notable cases to h........

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 Webinar Id: LSHRC001
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 Duration: 60 mins

CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing Ar........

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 Webinar Id: LSHCJW002
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 Duration: 60 mins

Structuring Physician Leases Under the New 2016 Stark Rules

In this session Mr. Wolfe will provide a general Stark Law overview. He will also discuss best practices for auditing existing space lease arrangements and for implementing new time-share arrangements under the new 2016 Stark rules. Background: CMS recently finalized a number of significant changes to the Stark Law for the 2016 calendar year. Now that these changes have gone into effect, health care organizations should be monitoring an........

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 Webinar Id: LSHC0019
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 Duration: 90 mins

Patients Suing under HIPAA - Beware of New Laws

There are major changes to HIPAA set forth by the Federal government whereby patients can receive remedies for HIPAA violations! Omnibus has changed the HIPAA landscape for good! State laws are now in place increasing liability for patient remedies! This once rarely enforced law has changed and you need to know what's going on! What factors might spurn a HIPAA audit? ...are you doing these things? We will be discussing some of the chang........

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 Webinar Id: LSHCCT006
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 Duration: 90 mins

FDA's Latest Regulations for Tobacco Industry Effective 8/2016

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens)........

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 Webinar Id: LSHCVS011
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 Duration: 180 mins

3-Hr Virtual Training: What to Expect in a Federal HIPAA Audit and How to Avoid an Audit Altogether

Brian will discuss changes with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books and new risks specific to business associates. It will also discuss factors that might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with federal and state laws. Brian will uncover myths versus reality as it relates to this very enigmatic law base........

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 Webinar Id: LSHC0018
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 Duration: 90 mins

HIPAA Phase 2 Audits - an inside look at what to expect

HIPAA NOW HAS TEETH! Phase 2 Audits and personal patient remedies have changed the landscape! This once relatively benign legislation is being fully enforced and the news is not good for covered entities or business associates! Be prepared! Protect your practice or business! What factors might spurn a HIPAA audit? ...are you doing these things? Why are the Feds enforcing after all these years?  We will be discussing some of the changes ........

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 Webinar Id: LSHCJW001
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 Duration: 60 mins

Auditing Physician Contracts Under the New 2016 Stark Rules

In this session Mr. Wolfe will provide an overview of the Stark Law and its 2016 changes. He will also discuss best practices for implementing and auditing physician compensation arrangements to minimize liability exposure and penalties, including conducting compliance audits, instituting policies, and establishing ongoing monitoring and review processes.

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 Webinar Id: LSHC0017
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 Duration: 90 mins

WHY YOU SHOULD BE WORRIED ABOUT HIPAA: A Boot Camp

Are you confused about HIPAA? Do you just want the basics and in plain English?  Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to porta........

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 Webinar Id: LSHC0022
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 Duration: 60 mins

Closing A Medical Practice

This workshop will discuss the ethical and legal tasks to close a practice. There are many tasks that must be accomplished and having an organized plan is essential.  

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 Webinar Id: LSHC0007
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 Duration: 60 mins

Beyond the Allegation: How to Effectively Conduct Compliance Investigations

This presentation provides a blueprint for how to conduct an effective compliance investigation. Since responding to detected offenses and developing corrective action plans are included in the Seven Elements of an Effective Compliance Program, this presentation is intended to aid compliance professionals with a consistent approach for conducting investigations, from gathering information to corrective action and everything in between. ........

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 Webinar Id: LSHC0005
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 Duration: 60 mins

Human Factors /Usability Study based on ISO 62366 and latest FDA Guidance.

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the........

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 Webinar Id: LSHC0014
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 Duration: 90 mins

HIPAA Breach Notification Rule: A Blueprint for Conducting Consistent Risk Assessments

This presentation will cover developing a blueprint for conducting risk assessments under the HIPAA Breach Notification Rule. More specifically, it will address topics such as what constitutes a breach, what to include in a Breach Notification policy, how to conduct a risk assessment analyzing any issue, and how to document your risk assessment. It will conclude with allowing time for questions and answers. This presentation will use a ........

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 Webinar Id: LSHC0002
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 Duration: 60 mins

Medical Devices - ISO 13485 - Do you really know what you need to?

ISO 13485 is for medical devices. So anyone that is currently or wants to develop components for and/or entire medical device products, they need to meet local regulatory as well as ISO 13485 standards.

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