William Bennett, PMP

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CAI
Associate Director, Global C&Q Business Area
Chip Bennett, PMP, is a QRM SME and Lead Commissioning, Qualification and Validation Program Development SME for CAI. A Project Manager and Senior Validation Engineer, Chip is a PMI Certifi ed Project Management Professional with 19 years of experience in the pharmaceutical and regulated nonpharmaceutical industries and with expertise in risk-based verifi cation, aseptic manufacturing, quality systems, and owner project management. Chip is responsible for developing and implementing QRM-based C&Q programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches. Chip has been an ISPE member since 2003.

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Good Engineering Practice in Risk-Based Commissioning & Qualification diagram
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Good Engineering Practice in Risk-Based Commissioning & Qualification

Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on engineering and the application of Good Engineering Practice (GEP) to provide documentation for the...