Device Corrections and Removals Webinar By GlobalCompliancePanel
Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?
If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.
Why should you attend: An FDA Inspection will check for Corrections and Removals during an inspection. Often Inspectors will check specific actions, since they will monitor your website and usually get a copy of letters you sent to customers. If you send a letter that notifies your customers of a problem, it will almost certainly get to a competitor who will send a copy to FDA. If you didn’t report to FDA, the Inspector will ask for your records documenting the reason not to report.
This webinar will clarify your obligations for corrections and Removal under Part 806. You will learn:
The requirements of Part 806 including the difference between reports and records
The difference between a correction and a removal and how to report them
The exceptions in Part 806 and how to apply them to make the reporting decision
What an Inspector will look for in a QSIT inspection
What to look for in an effective program and how to ensure your program makes the grade
The results of Warning Letters and how you can avoid some of the same issues
The relationship with design changes and the potential need to update a 510(k)
Areas Covered in the Session
The basic requirements of Part 806
When to report
Exemptions that you may apply
Reporting under Part 803 - Medical Device Reports
Reporting under Part 1004 - Repurchase, Repairs, or Replacement of Electronic Products
The requirements of a report and the timing
The requirements for records when you don’t report
The expectations of a QSIT Inspection
Elements of a robust system
How to check your system for compliance
Design changes and potential 510(k) submissions
The current guidance
The draft guidance
Who Will Benefit:
Risk Management Specialists
Complaint Managers and Specialists
Regulatory/Legislative Affairs Professionals
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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