Managing Product Corrections & Removals in Accordance with 21 CFR, Part 806

Compliance with 21 CFR, Part 806 (Medical Devices; Reports of Corrections and Removals) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by recall classification (three device classes in the U.S.). The Recall Classification (1, 2, or 3), premised on risk, will drive the amount of oversight and reporting required by FDA. A medical device recall is always a challenging event for device manufacturers because it is an activity that hopefully is not called upon much. However, having a well-documented approach to managing recalls and employees that are appropriately trained are key in executing recalls successfully.

If your organization is struggling with understanding the salient requirements associated with 21 CFR, Part 806, this webinar is for you. This webinar will help your organization better understand the FDA’s expectations for implementing an effective recall program, including tools needed to successfully execute product recalls including:
(a) creation of a recall notification packet
(b) product recovery and quarantine
(c) reporting required by FDA
(d) product rework and/or destruction
(e) effectiveness checks
(f) closing the recall.

For establishments already having a compliant approach for corrections and removals, this webinar will help your organization streamline their approach to managing recalls effectively.

Areas Covered in the Session :
Reviewing and understanding the requirements associated with 21 CFR, Part 806 compliance
Regulatory and statutory requirements
Recall classification
The recall process
Notifying FDA
Creating the recall notification packet
Notifying customers
Product recovery and quarantine
Periodic reporting requirements
Effectiveness checks
Third-party providers
Product disposition (rework and/or destruction)
Closing the recall

Who Will Benefit:
Quality Professionals
Regulatory Professionals
Risk Management Specialists
Complaint Managers and Specialists
Compliance Officers
Customer Service Professionals
Sales/Marketing Professionals
Senior and mid-level Management

Dr. Christopher J. Devine

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.

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  • Presentation from the Speaker
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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance