Xavier Health
QA/RA Institute for Medical Device Professionals
 

Post-Market Surveillance Series


Download Summary of Post-Market Surveillance Series

Course Format:

  • Webinar

Expert Faculty:

Series Description:

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:

  1. Post-Market Surveillance: An Introduction
  2. Complaint Handling
  3. MDR
  4. Vigilance
  5. Corrections & Removals (US) or Recalls (abroad)
  6. 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 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**

Course Introduction:

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.

Course Certificates:

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.

Tuition:

Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.

Industry: $1890.00
†Small Companies: $1485.00
†††Startup/Academic: $405.00
Government Official: $0.00

Attendee Types
† A Small Business is one that has less than 100 employees.

††† A Start-up Company is one that manufactures product. A start-up company who provides only services is not included in this category. The start-up company must not have product on the market yet, and therefore no revenue being generated. The start-up company has less than 10 employees.

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.

Logistics:

This webinar series is now available for immediate access.