The Correction and Removals Guidance - Webinar CD/Transcript

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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:

  • The requirements of Part 806
  • 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 investigator will look for in a QSIT inspection
  • What to look for in an effective program
  • The observations in warning letters and how you can avoid the same mistakes
  • How to make design changes and when you need to update a 510(k)

BONUS MATERIALS — All attendees will receive the following materials to help implement the regulations:

  • A copy of the final guidance document
  • A copy of the Corrections and Removal regulation, formatted for easier reading
  • An Excel spreadsheet that will help you determine if the event is reportable
  • A comparative analysis of the definitions in the Recall regulation (Part 7) and the Correction & Removal regulation (Part 806)

Order today and gain a better understanding of how your records and reporting relate to corrections and removal.

  • Quality Assurance
  • Design Engineers
  • Design Project Managers
  • Regulatory Affairs
  • Legal counsel
  • Complaints specialists
  • Medical device reporting specialists
  • Field change specialists
  • Risk Management specialists

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.