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The Correction and Removals Guidance: Understanding and Implementation
It’s been two years since the guidance was published and device manufacturers are still confused about what to do when it comes to corrections and removals.
Corrections and removals are intertwined with design changes, device improvements and recalls.
How can you tell the differences between a device enhancement — which is not reported to the FDA — a reportable activity and reporting exceptions?
Understanding the definitions is hard enough… but when those definitions don’t agree across the various applicable regulations you need help.
Join industry expert Dan O’Leary for an in-depth explanation. Dan will start with the difference between an enhancement and a reportable change — a change the FDA would classify as a recall. Then, he’ll clarify which changes are not reportable. He’ll explain these ideas using examples, warning letters and recalls.
After attending this 90-minute session you will understand:
BONUS MATERIALS — All attendees will receive the following materials to help implement the regulations:
Order today and gain a better understanding of how your records and reporting relate to corrections and removal.
Dan O’Leary 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 year’s experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s 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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