Richard Bigg, MA, MBA, MS

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Process Validation

Richard Bigg has over thirty years of pharmaceutical quality and manufacturing experience. During the past decade, he has been a project manager for validation efforts, including computerized systems, manufacturing, laboratory software and hardware, manufacturing facilities, processes, equipment and cleaning, and plant utilities and HVAC systems. He has developed and written numerous SOPS, validation plans and protocols, and final reports and has addressed many organizations, including the Organic Chemical Manufacturers Association, the International Society for Pharmaceutical Engineering, and the ASQ CFDC/FDA Conference. In addition to an MBA in Finance and an MS in Chemistry from Seton Hall, he obtained an MA in Counseling from Montclair State and has a private psychoanalytic practice specializing in narcissistic disorders. A certificated Quality Engineer, he is a member of the American Chemical Society, the American Society for Quality, and the International Society for Pharmaceutical Engineering.

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