Managing Product Recalls in Accordance with Part 806

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It is inevitable that eventually a device manufacturer will need to execute a correction or market-withdraw for a medical device. The actual process of managing a market-withdraw is time consuming; and if poorly executed can result in a visit from the FDA, while alienating the customer base. It is not unusual for FDA to spend a fair amount of time reviewing the recall files during an inspection, especially if the device establishment has executed a Class I or Class II recall since their previous establishment inspection.

Device establishments that have a well-defined process for managing product recalls typically avoid many of the pitfalls associated with managing recalls in the fire-fighting mode. Granted, product recalls are challenging events, device establishments can benefit when recalls are efficiently and effectively executed. This Webinar breaks down the elements associated with the product recall process and provides attendees with a fundamental understanding of the FDA’s recall requirements delineated within Part 806, while providing the tools needed for compliance.

Areas to be Covered:

21 CFR, Part 806 compliance requirements
Understanding the different types of field actions:
Market withdraw
Stock recovery
Classification of Recalls
Creating an effective Recall Packet
The recall notification process
Reporting recall-related activities to the FDA (required reports)
Recovery and quarantine of product
Disposition of recalled product (certified destruction or rework)
Formal closeout of a recall, including the FDA notification process

Who will Benefit:

Beneficiaries of this Webinar will be
Quality Professionals
Regulatory Professionals
Customer Service Professionals
And everyone involved in the recall process, including the customer notification process, FDA notification process; creation and issuance of recall packets; product recovery process; product quarantine process; management of 3rd-Party Recall Service Providers; and the destruction of recalled product.

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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • 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