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
The recall process
Creating the recall notification packet
Product recovery and quarantine
Periodic reporting requirements
Product disposition (rework and/or destruction)
Closing the recall
Who Will Benefit:
Risk Management Specialists
Complaint Managers and Specialists
Customer Service Professionals
Senior and mid-level Management