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 6 modules covering the following topics in detail:
This series is a continuation of our MDR webinar series (also designed by Sharon Kapsch). We highly recommend (but not required) that you watch the MDR series prior to attending the Post-Market Surveillance series in order to achieve maximum value.
**Receive a 10% Discount for purchasing all 6 modules**
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 & Removals, and operational strategy. Join FDA and industry experts for this dynamic series that will enhance your post-market system.
Each participant will receive a certificate of completion after each module attended upon the return of a completed evaluation form: CEU Evaluation. Each participant will receive 0.1 CEU credits per hour of training.
Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.
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.
This webinar series is now available for immediate access.