Transcription of Process Validation for Medical Devices - Ombu …
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Process Validation for Medical Devices - Ombu …
Process Validation for Medical Devices1 Ombu EnterprisesProcess ValidationforMedical DevicesDan O Leary CBA, CQE, CRE, CSSBB, CIRMOmbu Enterprises, 2010 by Ombu Enterprises, LLCP rocess Validation for Medical Devices2 Ombu EnterprisesInstructor Introduction Dan O Leary 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 Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. Ombu Enterprises, LLC Ombu works with small manufacturing companies, offering training and execution in Operational Excellence.
Process Validation for Medical Devices 6 Ombu Enterprises Process Validation • The Problem – The product (in-process or final) that results from a process
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