Speaker Profile


Dan OLeary

President, Ombu Enterprises

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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  • Recorded
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  • 75 Minutes
  • ¤189.00
Statistical Concepts of Process Validation

The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".

  • Recorded
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  • 90 Minutes
  • ¤189.00
Device Corrections and Removals

When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

  • Recorded
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  • 75 Minutes
  • ¤189.00
Regulatory Requirements for Medical Device Calibration Programs

Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
Acceptance Sampling by Variables

Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes.

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161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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