5 Design Change Considerations to Stay Compliant - Webinar Recording/Transcript

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5 Design Change Considerations to Stay Compliant

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Medical device design change is a demanding and uneasy process. Failure to dot all your i’s and cross all your t’s can lead to inspection problems on the downside and missed market opportunities on the upside.

FDA QSR §820.30(i) spells out the basics but 820.30(i) is only the starting place for you and the team. FDA’s QSIT tells investigators that production and process changes under §820.70 may also be design changes under §820.30(i). Also in play: 21 CFR §820.75 and ISO 13485:2016. It’s complicating your processes.

Here to straighten things out is Dan O’Leary, FDAnews’s expert on all things technical involving medical devices — and one of our most sought-after presenters. 

Presentation Takeaways:

  • Relationship among design output, design transfer and production control
  • Reason why the FDA may deem a production change to be a design change
  • Elements of the new UDI rule including the Device Identifier (DI)
  • Triggers that create a new DI and how to document your decision
  • Requirement to evaluate change significance for possible 510(k) submission
  • Use of the 510(k) change guidance documents
  • Changes to the risk management file resulting from a design change
  • Implications for FDA inspections

Special Bonus Materials: Checklists you will use to ensure effective implementation.

If your responsibilities include production and process changes, then you need to determine whether they are design changes and how to implement them. If they include design changes, then you need to understand all the considerations for a complete and compliant change and the associated records. And that’s exactly what you get when you check in with Dan O’Leary!

Design change is usually a cross-function and multi-discipline team endeavor. Team members who should attend include:

  • Design Engineers
  • Manufacturing Engineers
  • Quality Engineers
  • Risk Managers
  • Quality/QSR
  • GMP and cGMP
  • Regulatory Affairs

Dan O’Leary, one of FDAnews’s most sought-after presenters, is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He 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.