CoP Session: C&Q Hot Topics
11:30 AM – 12:00 PM | East Red Level, Suite 20
C&Q CoP Hot Topics – Benchmarking and Regulatory Update
- Review latest survey results and data
- Review of Annex 15 and ISPE Baseline Guide Vol 5
Speakers:
Nathan Temple, Global Director of Commissioning and Qualification, CAI
Stephanie White, Global Validation Director, Emergent BioSolutions
Biographies:
Nathan Temple, Global Director of Commissioning and Qualification, CAI
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.
Stephanie White, Global Validation Director, Emergent BioSolutions
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. She enjoys spending time with her family where she lives on the coast of NC boating, fishing, and hanging out at the beach and her favorite past time is watching her son and grandson play sports.
