About the webinar
Over the years, the roles and responsibilities of engineering and quality/validation for commissioning and qualification (C&Q) activities have evolved. C&Q approaches based on quality risk management (QRM) principles, such as the process defined in ISPE Baseline Guide Volume 5, Commissioning and Qualification, 2nd Edition (2019), now rely more than ever on engineering and the application of good engineering practices to provide documentation that is part of the qualification package. What role does engineering play in QRM-based C&Q? This webinar will discuss the current industry transition of primary responsibility for process manufacturing performance verification from quality/validation to engineering – a transition that equips both engineering and quality with the tools to deliver true quality by design, resulting in improved product quality (patient safety) and faster time to market.

About the moderator
Chip Bennett, PMP
Deputy Director, Global C&Q, CAI
Chip is a Project Manager and Lead Validation Engineer and a PMI® certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems and owner project management. Chip is responsible for the development and implementation of Quality Risk Management (QRM) based commissioning and qualification programs and projects, with a focus on assessing and training clients on the development, implementation and transition to risk-based approaches.

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