CoP Session: C&Q Hot Topics
1:00 PM – 2:00 PM | Red Level Press Box
Implementing a QRM-Based Commissioning and Qualification (C&Q) Process in Pharmaceutical Manufacturing
This presentation will provide an in-depth overview of the QRM-based integrated approach to Commissioning and Qualification (C&Q) as outlined in the ISPE Baseline® Guide Volume 5 and its 2025 Addendum. It focuses on aligning Good Engineering Practice (GEP) with Quality Risk Management (QRM) to achieve GMP compliance, reduce regulatory inspection risk, and accelerate project delivery. The session will emphasize the tangible business and quality benefits of this science- and risk-based methodology, including speed to market, improved compliance, and streamlined project execution.
Speakers:
Paul Meehan, Sr. Director QA Validation, Ultragenyx
Shawn Phillips, Associate Director CQV, CAI
Nathan Temple, AVP-Operational Readiness, CAI
Biographies:
Paul Meehan, Sr. Director QA Validation, Ultragenyx
Paul Meehan’s experience has included both engineering and quality roles supporting commissioning, qualification, and validation activities mostly within biologics and is currently supporting the startup of a gene therapy manufacturing facility.
He was a former chair of the ISPE C&Q COP Steering Committee. Mr. Meehan holds an MBA degree from Boston College, a B.S. degree in Mechanical Engineering from Boston University, and an ISPE CPIP certification.
Shawn Phillips, Associate Director CQV, CAI
Shawn Phillips is a CQV discipline lead with 30 years’ experience in the pharmaceutical and biopharmaceutical industry with extensive knowledge of new facility start-ups, product technology transfers (i.e. Cleaning Validation), deployment of new technologies, implementation of Pharmaceutical Quality Systems, and Paperless Qualification tools (i.e. VLMS). Shawn is an innovative leader with significant test execution and project management experience over a wide variety of systems, equipment and program implementations. Shawn is a CQV strategy implementation and deployment subject matter expert providing project consulting and support.
Nathan Temple, AVP-Operational Readiness, CAI
Nathan Temple serves as the CAI Global Director for Commissioning, Qualification and Validation, is a PMI® Certified Project Management Professional (PMP) and licensed Professional Engineer with 25+ consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification. Nathan has extensive engineering, test execution, and project management experience with a wide variety of systems and equipment. Nathan is a computer system validation subject matter expert providing project consulting and support. He is the Chair of the ISPE C&Q Community of Practice Steering Committee. Nathan is a sought-after expert in the areas of C&Q program implementation and optimization with emphasis on integrated C&Q and ISPE C&Q Baseline Guide 2nd Edition QRM based C&Q. His focus is enhanced project delivery for operational readiness and speed to market.
