Corrections and Removals - Understanding and Implementing the Final Guidance Document

Duration: 90 Minutes
Making changes to product in the field can raise some regulatory hurdles for device manufacturers. One issue, for example, is determining when a design change should include a field action. The regulations are not always clear, especially when reviewing Part 806 which can lead to recall action under Part 7. The definitions in these parts don't even agree. FDA had been concerned that companies would not enhance medical devices for fear that FDA would classify the enhancements as a recall. To help resolve the situation, FDA prepared a draft guidance document.
Instructor: Daniel O'Leary
Product ID: 501082
On October 15, 2014, FDA-CDRH published the final version of the guidance. Unfortunately, it still leaves some issues open. This webinar helps you understand the difference between an enhancement, which is not reported to the FDA, potentially reportable changes, and the reporting exceptions. The webinar starts with the difference between an enhancement and a reportable change, i.e., a change that FDA would classify as a recall. It also clarifies changes that are not reportable. The webinar explains all of these ideas using examples, Warning Letters, and Recalls.

Objectives of the Presentation
  • The provisions of the regulations that relate to devices with problems
  • The guidance document and its intention and use
  • The regulations for correction & removal
  • The four exemptions for reporting
  • The need to keep records when a change is not reportable
  • How FDA will classify the report as a recall
  • You obligations to manage the recall
Why Should you Attend
Your QMS is at risk if you do not properly classify design changes, determine which might be reportable, and apply the reportability criteria. In some cases you report changes to FDA and in other cases you keep a quality record demonstrating that the event was not reportable.

In particular, you need to be clear about the status of any communication with a customer related to device problems and potential fixes. Expect that FDA will learn of them and, as a result, trigger an inspection.

Who can Benefit
Professionals from device companies involved in production changes, design changes, medical device reporting, and field actions:
  • Quality Assurance
  • Regulatory Affairs
  • Legal Counsel
  • Complaints Specialists
  • Medical Device Reporting Specialists
  • Field Change Specialists
  • Risk Management Specialists
*Bonus Materials
Participants will receive bonus materials to help them 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)
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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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