CoP Session: C&Q CoP – Trends and Current Initiatives
12:30 PM – 1:00 PM | West Red Level, Suite 70
In this session the speakers will discuss the mission and structure of the C&Q COP. Trends and current initiatives will be presented as well as QRM based C&Q, benchmarks and paperless validation. They will bring to you how you can get involved.
Speakers:
Stephanie White, Emergent, Director Global Validation
Nathan Temple, CAI, Global Director CQV
Stephanie White MS, is currently the Global Validation Director at Emergent BioSolutions. She has 20+ years’ experience in the biological pharmaceutical industry working in R&D, drug substance, drug product, fill-finish, and combination products. She also is engaged with ISPE as a member of the C&Q Steering Committee and was a co- author with other industry profession on Good Practice Guide: Good Engineering Practice, Volume 2. Her passion is to help standardized engineering and validation processes resulting in increased efficiencies and effectiveness providing value to capital project delivery.
Nathan Temple serves as the Global Director of Commissioning and Qualification for CAI, is a PMI® Certified Project Management Professional (PMP) and licensed Professional Engineer with 20+ 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 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 operational readiness.
