Alice Redmond, PhD. is a Vice President with Commissioning Agents, Inc. She formerly worked as CQ Technical Director with PM Group, she has over 20-years’ worth of experience in R&D, Pharmaceutical (API, Formulation Fill, Solid dosage) and Biotechnology the industry. Alice graduated with a BSc in Biotechnology in 1987, PhD in Biotechnology in 1991 and a MBs in 2001. Current responsibilities include oversight of regulatory compliance, GEP, quality, commissioning, qualification and validation strategies on a corporate level for PM Group. Alice has led number C&Q projects for numerous multinational clients on a global basis and is currently actively working on Consultancy assignments including ASTM E2500-07 implementation, Technology transfer, process validation, lean C&Q and practical risk assessment strategies. Alice is an active member of the ISPE and PDA, and was a recent award winner of 2009 ISPE article of the year for ‘An Industry perspective on the Draft Process Validation Guide.'