Medical Device Complaints, MDR’s and Recalls - Webinar By ComplianceOnline (Medical Device)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Oct 24, 2011 End Date/Time: Oct 24, 2011
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Why Should You Attend:
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)
Complaint Documentation
Part 803 - Medical Device Reporting
Part 806 - Reports of Corrections & Removals
Warning letters and other FDA Remedies
Complaint Handling Pitfalls

Note: Use this promocode(117660) for 10% discount.


Online Event
2600 E. Bayshore Road
Palo Alto
United States