Medical Device Complaints, MDRâ€™s and Recalls - Webinar By ComplianceOnline (Medical Device)
Venue: Online Event
|Event Date/Time: Oct 24, 2011||End Date/Time: Oct 24, 2011|
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 FDAâ€™s website and published in trade magazines, newspapers available to firmâ€™s competitors, and has even driven the firmâ€™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
Note: Use this promocode(117660) for 10% discount.