This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
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 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 the seminar:
- 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:
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Some employees who wish to gain a better understanding include:
- Quality & Regulatory Professionals
- Manufacturing & Design Engineers
- Marketing Product Managers
- Corporate & Operations Executives
Instructor Profile:
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory 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. RAB Accredited Lead Auditor Course Certificate1996. 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.
John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented seminars on various regulatory subjects.
