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. Focusing on the analytic skills and systems approach of operations management, Ombu helps companies achieve efficient, effective Process and regulatory Validation for Medical Devices3 Ombu EnterprisesParticipant Introduction Your Name Your company Your job title Something about the Process Validation issues you face in your company Something about what you want to knowProcess Validation for Medical Devices4 Ombu EnterprisesOur Class Our approach is casual Write your name on a table tent Turn off your cell phones for the class Ask lots of questions

Process Validation for Medical Devices 2 Ombu Enterprises Instructor Introduction • Dan O’Leary – Dan has more than 30 years experience in quality, operations,

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