Why Should You Attend:
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.
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 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.
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.
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 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.
Speakers
John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for 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.
Mr. Chapman 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 live online seminars on various regulatory and quality system subjects.
