Many companies are confident that their complaint handling systems are compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 complaint handling cites are written and warning Letters, seizures or worse ensue. This presentation will review the sections of the QS Reg. Complaint handling rules. Actual field complaint/FDA data will be discussed, and trends from FDA will be discerned from the data. FDA investigator techniques regarding complaint handling investigations will also be discussed.
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What Will Students Learn:
Who will benefit:
This webinar will provide your firm with key insights on how to identify compliance gaps in your complaint handling processes. The webinar will help you avoid FDA 483’s and warning letters the employees who will benefit include:
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.
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