Device Recalls & Vigilance - When to Report Complaints – Part 803 and Part
This Device recall & reporting webinar will highlight pitfalls in compliant handling and reporting. It will
give a better clarity on regulatory process and terms by reviewing the FDA regulations governing
recalls and reporting.
Why Should You Attend:
FDA has explicit complaint handling requirements and procedures. However due to inadequate
compliant handling system/process many medical device firms face regulatory issues in both the
European Union & the USA. Poor or inadequate compliant handling can be quite expensive resulting in
poor customer relations, loss of sales. On top of that failure to report problems to regulatory agencies
promptly results in costly regulatory action . 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 this webinar:
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.
Who Will Benefit:
This Webinar will explain the regulatory process and in understandable terms. Employees who wish to
gain a better understanding include:
Quality & Regulatory Professionals
Manufacturing & Design Engineers
Marketing Product Managers
o Senior Management
o Customer Support Personnel
o Agents and Distributors
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10
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. 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.