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Medical Device Process Validation
Process valiation can be a daunting propect. What should you do? When should you do it? What records should you keep?
With no clear guidance from the FDA, finding the answers can be difficult.
Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, as he discusses the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices.
After attending this 90-minute training session you will:
Order today and discover how to set up a compliant process validation system.
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.
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