A 2011 IOM report (“Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years”) recommended that the FDA strengthen post-market surveillance activities in order to better protect patients and to better utilize post-market data. Therefore, the FDA has placed creating a more comprehensive medical device post-market surveillance strategy as one of their top strategic priorities of 2013.
In an effort to strengthen the industry’s post-market activities, Sharon Kapsch, Chief of the MDR Policy Branch within FDA CDRH’s Office of Surveillance and Biometrics, has helped design this series to provide an intermediate level of understanding to achieve a robust post-market surveillance strategy. There will be six modules covering the following topics in detail:
- Post-Market Surveillance: An Introduction
- Complaint Handling
- Corrections and Removals (US) or Recalls (abroad)
- Overview: Operationalizing Post-Market Surveillance in a Global Company and Panel Discussion
This series is a continuation of our MDR webinar series (also designed by Sharon Kapsch). We highly recommend (but not require) that you watch the MDR series prior to attending the Post-Market Surveillance series in order to achieve maximum value.
Receive a 15% discount for purchasing all six modules!
Director, Product Surveillance
Chief, MDR Policy Branch, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA
Lead Quality System & Compliance Consultant
King & Spalding
Postmarket Surveillance Director
(Expert faculty titles and companies may have changed since time of recording.)
This six-webinar course series will focus on the key aspects of a robust post-market surveillance system including: a broad overview perspective, complaint handling, MDR, vigilance, corrections and removals, and operational strategy. Join FDA and industry experts for this dynamic series that will enhance your post-market system.
Who Should Attend
All functions related to quality and regulatory affairs, with specific focus on all systems that touch post-market surveillance, such as corrective actions/preventative actions, complaints, investigations, and recalls.
Each participant will receive a Certificate of Completion after each module attended upon the submission of a completed evaluation form. Each participant will receive 0.1 CEU credits per hour of training. Access to webinar/s and link to the CEU evaluation form will be provided upon purchase.
Video run-times are in parentheses.
- Post-Market Surveillance Series Module 1: Introduction to Post-Market Surveillance (59:19)
- Post-Market Surveillance Series Module 2: Complaint Handling (1:07:06)
- Post-Market Surveillance Series Module 3: Medical Device Reporting (MDR) (1:07:19)
- Post-Market Surveillance Series Module 4: Vigilance (1:07:48)
- Post-Market Surveillance Series Module 5: Corrections and Removals or Recalls (2:05:08)
- Post-Market Surveillance Series Module 6: Operationalizing Post-Market Surveillance in a Global Company (1:32:43)
Registrants may purchase all six modules at a 15% discount, or may purchase individual modules at $99 each using the links above.
$500 for entire series (includes a 15% discount for purchase of all six modules)
Government Official: $0.00 (must have valid .gov email account)