This webinar on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
All Medical Device firms need to be aware of the benefits of compliance, as well as the dangers of inadequate complaint handling.
Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters.
FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
Areas Covered in the Seminar:
FDA's Complaint Definition 820.3 (b)
Part 803 – Medical Device Reporting
Part 806 – Reports of Corrections & Removals
Warning letters and other FDA Remedies
Complaint Handling Pitfalls
(Courtesy of The Palo Alto - wikipedia.org/wiki/)
Tue, Feb 05, 2013 - Tue, Feb 05, 2013
Online Event - 10:00AM to 11:00AM (GMT-08:00) Pacific Time (US & Canada)
2600 E. Bayshore Road, Palo Alto, United States
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