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

David R. Dills, Regulatory Affairs & Compliance Consultant is a Keynote Speaker at Compliance Key INC provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also ha

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Overview
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 pique our interest, ensuring the integrity of data and the protection of participants during the conduct of clinical research is an ongoing process. Developing and incorporating systems for detecting and preventing fraud should be a standard part of any compliance plan.We will address this and much more.
 
Why should you attend this webinar?
  • Learn more about the regulatory and compliance expectations for postmarket surveillance and complaint handling and how to apply the requirements to medical devices
  • Understand and apply the elements comprising an effective complaint handling system, vigilance system, reporting requirements and implementation challenges
  • Have a better overview of the compliance requirements and the most recent FDA/regulatory inspection trends
  • Achieve compliance success with your postmarket surveillance and complaint handling programs
 
Areas Covered in the Session:
  • Learn the regulatory background of fraud and the criteria for characterizing misconduct as fraud
  • Define the basic requirements of Good Clinical Practices
  • Determine the appropriate responsibilities and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
  • Quality practices that are designed and implemented to guarantee compliant clinical trials
  • FDA GCP inspections and recent trends
  • Define, and differentiate between, fraud and misconduct/noncompliance
  • Develop an understanding of why and how fraud occurs
  • Examine methods for detecting and preventing fraud and misconduct
  • Explain the Sponsor/CRO, IRB, Clinical Investigator, and Study Staff role in detection and prevention 
  • Identify and establish methods to uncover and preclude fraud and misconduct in clinical trials
  • Develop trial guidelines and a framework which will easily identify any misconduct and which is capable of quickly addressing any issues that arise in order to avoid regulatory consequences
  • Enforcement Actions
 
Who can Benefit:
All levels of Management for all departments and those who desire a better understanding, overview and/or refresh of GCP audits, recent FDA enforcement activities, and certainly uncovering any potential misconduct and fraud in clinical trials, including:
  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Clinical Investigators
 
Product Id : LHSCDRD001
Training Options                        Duration: 60 mins
07/06/2017  10:00 AM PST | 01:00 PM EST
Single Attendee:   [Only for one participant]
Price: $165 (Live) Price: $270 (Live + Recorded)
Multiple Attendee:   [For a group of 2 to 5 participants]
Price: $335 (Live) Price: $440 (Live + Recorded)
Corporate Attendee:   [For a group of 6 - 10 Participants]
Price: $670 (Live) Price: $775 (Live + Recorded)
Recorded   [Six month unlimited access]
Price: $193
     Refund Policy
 
Upcoming Webinar of David R Dills
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Live 07/06/2017  Time: 10:00 AM PST | 01:00 PM EST
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
Live 07/20/2017  Time: 10.00 AM PST | 01.00 PM EST
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