Device Corrections and Removals - Webinar By ComplianceOnline (FDA GXP Compliance -)
Venue: Online Event
|Event Date/Time: Jun 01, 2012||End Date/Time: Jun 01, 2012|
When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA?
If you send a letter to a customer that says, â€œWe found a problem, but, not to worry, we will fix it for you!â€, 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.
An FDA Inspection will check for Corrections and Removals since it is part of QSIT. Often Inspectors will check specific actions, since they will monitor your website and have copies 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 didnâ€™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.