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:
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
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.