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9781041371151

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Guy Wingate, Ph.D., was Vice‑President of Compliance and before that Director of Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP® Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.

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