Device Recalls & Vigilance - When to Report Complaints – Part 803 and Part 806 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. Description 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). Complaint Documentation. 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
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Senior Management Customer Support Personnel Agents and Distributors
Instructor Profile: 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.