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Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. 
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry.More recently, Ms Bazigos was quoted in the Wall Street Journal on Bringing Compliance to the Boardroom 

 Webinar Id: LSHCAB005
12:30 PM PT | 03:30 PM ET
 02/05/2018
 Duration 90 mins

Current Concepts & Challenges in Cloud Compliance

The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services; review 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: LSHCAB001
12:30 PM PT | 03:30 PM ET
 03/14/2018
 Duration 90 mins

Regulatory Issues in Pharmacogenomics

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study of the role of genetics in drug response. It deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with drug absorption, distribution, metabolism and elimination, as well as drug receptor target effects. Pharmacogenomics may be used interchangeably with the term pharmacogenetic........


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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: LSHCAE001
12:30 PM PT | 03:30 PM ET
 05/07/2018
 Duration 90 mins

Excel Spreadsheet 21 CFR 11 Compliance

This webinar will describe the regulatory and business requirements for Excel spreadsheets,using examples from FDA recommendations.It will then cover the design and installation of those Excel Spreadsheets,to ensure the integrity of the data,and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.


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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: LSHCWA001
 View Anytime
 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: HIPAB001
 View Anytime
 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........

$447 Recorded (6 months unlimited access)

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 Webinar Id: LSHCAB003
 View Anytime
 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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