Science and Risked Based C&Q

Companies need practical advice and examples in order to efficiently and effectively deploy ASTM E 2500-based C&Q approaches. This session is made up of two distinct but interrelated segments: (1) The Pharma Manufacturer’s C&Q Risk Approach Task Team Forum V segment will be a follow up on the sessions held at Annual Meetings since 2009. (2) Practicial example case studies from two actual projects. • Create or enhance current C&Q program with solid risk-based principles • Develop specific risk-based C&Q tools and work instruction for limplementation • Understand challenges and approaches