Innovative Process Validation Strategies for Medical Devices


Innovative Process Validation
Strategies for Medical Devices:
Proving Your Processes and
Documentation to the FDA

Bethesda, MD (Washington, DC) • Aug. 26-27, 2014


Meet Your Presenter


Dan O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. 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.