Day 1 – Session

A session at 2-day In-person Seminar on “Quality Audits for the Medical Device Industry” at Raleigh, NC

Thursday 30th October, 2014

9:00am to 6:00pm (EST)

Lecture 1: Audit requirements in QMS standards
ISO 13485:2003
ISO 9001:2008

Lecture 2: Setting up the audit program
Lecture 3: Auditor Qualifications
Lecture 4: Planning the Audit
Lecture 5: Conducting the Audit
Lecture 6: Audit Sampling Plans
Lecture 7: Reporting the Audit

About the speaker

This person is speaking at this event.
Dan O'Leary

President, Ombu Enterprises

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 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.

1 attendee

  • Dan O'Leary

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Time 9:00am6:00pm EST

Date Thu 30th October 2014

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