Penny Butterell has 18 years of experience developing and managing all aspects of validation in the pharmaceutical industry. She has been a member of the Pfizer Global Quality Operations Validation team since 2002. Her areas of focus are the implementation of Continuous Quality Verification and the use of compliant science- and risk-based validation principles across Pfizer and through the product lifecycle. She is also supporting global initiatives to implement the principles of ICH Q9 and Q10. She joined Pfizer in 1998 as Validation Engineer at the API manufacturing site in Sandwich, UK. Prior to Pfizer, she worked for Sanofi-Aventis with responsibility for validation in sterile manufacturing (including isolator technology), oral solid dose and API. Her career started at Honeyman Associates, with design, construction and validation of pharmaceutical water systems. Penny holds a Bachelor’s degree in Chemistry from the University of Edinburgh, Scotland and is a member of ISPE.