Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: John Chapman
This webinar will help you to understand complaint handling processes and to reap the benefits of valuable product feedback. The identification of the problem, actual cause of the problem,documentation and regulatory reporting is discussed.Consequences of inadequate investigations are pointed out,including FDA Warning Letters and financial losses.The presentation will also review the regulations and point out some of the pitfalls as well as benefits of complaint handling and reporting.
Why should you Attend: Many medical device firms face significant regulatory issues as a result of inadequate complaint handling, most of which are quite costly. 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.
Areas Covered in the Session:
– FDA’s Complaint Definition 820.3 (b)
– Complaint Documentation
– Investigation & Root Cause
– Part 803 – Medical Device Reporting
– Financial and Business Repercussions
– Part 806 – Reports of Corrections & Removals
– Warning letters and other FDA Remedies
– Complaint Handling Pitfalls
Who Will Benefit:
– Quality & Regulatory Professionals
– Manufacturing & Design Engineers
– Marketing Product Managers
– Corporate & Operations Executives
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.