Medical Device Warning Letters – Webinar Recording/Transcript

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Medical Device Warning Letters: The Forgotten Five of the Most Cited Observations

Are you protected from the Forgotten Five most cited warning letter observations? If you’re not sure, you’re not alone.

Find solutions by understanding the Forgotten Five — the five highest-risk areas that prompt 483s and warning letters. The Forgotten Five are not frequently discussed and have not generated much corrective information. In other words, the Forgotten Five are the highest-risk areas that offer you the most potential to prevent inspection issues.

Dan O’Leary, President of Ombu Enterprises, LLC, is the perfect person to explain the Forgotten Five to you. Ombu maintains a database of all device warning letters from 2008 on. His firm’s analysis of this material has identified the Forgotten Five: the most frequently cited sections in the regulations with the least amount of information on how to deal with them. Addressing the Forgotten Five will give you the biggest impact for the effort.

This is your opportunity to adjust your processes to protect your business and ensure inspections go smoothly.

Presentation Takeaways:

  • The most commonly cited sections in warning letters
  • The distribution of warning letters by source, region and part
  • The Forgotten Five — the bottom 5 of the top 10 — most cited observations
  • The issues cited in the warning letters
  • How to address the issues before the inspection

Bonus! You’ll receive helpful checklists you can implement immediately for each of the Forgotten Five, effectively protecting your business against 483s and warning letters.

If you aren’t protecting your manufacturing processes against the Forgotten Five, you’re still highly vulnerable to 483s and warning letters. Change that with this presentation.

  • Design Engineering Managers
  • Design Project Managers
  • Design Engineers
  • Quality Managers
  • Quality Engineers
  • Documentation Specialists
  • Regulatory Affairs Specialists

Meet Your Presenter

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. Mr. O’Leary has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. 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.