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Medical Device Complaints, MDR's and Recalls
This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
Why Should You Attend:
All medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. Many medical device firms face regulatory issues as a result of inadequate complaint handling.
FDA has explicit complaint handling requirements and poor complaint and reporting procedures often resulting 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 and Removals
- Warning Letters and Other FDA Remedies
- Complaint Handling Pitfalls
Who Will Benefit:
- Quality and Regulatory Professionals
- Manufacturing and Design Engineers
- Marketing Product Managers
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.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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