QRM based Commissioning and Qualification

Описание: About the Webinar
Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, 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) rely heavily on Engineering and the application of Good Engineering Practices to provide documentation that forms part of the qualification package. What role does Engineering play in QRM-based C&Q? This webinar discusses the current industry transition of principle ownership of process manufacturing performance verification from Quality/Validation to Engineering – a transition that empowers both Engineering and Quality with the tools to deliver true Quality by Design, resulting in improved product quality (patient safety) and increased speed to market.

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