About the educational Session
US FDA first endorsed a risk-based approach to GMP in 2002, and GAMP5 translated this into a computerized systems validation (CSV) approach in 2008. Even now in 2020, many companies are still uncertain how to apply a risk-based approach to their own systems. The recent industry buzz around computer software assurance (CSA, a proposed US FDA guidance) has really only added to the confusion. The presentation will work through the critical thinking and understanding of business process, system Lifecycle and data lifecycle needed to successfully validate a system for its intended use.
About the Presenter
Charlie Wakeham has more than 20 years of industry experience developing and validating computerized systems for regulated production and laboratory environments. As Waters Corporation’s Regional CSV Consultant, she provides practical and pragmatic computerized systems validation assistance and data integrity consultancy to regulated companies implementing Laboratory Informatics in Korea and other Asia Pacific countries.
Charlie has been active within GAMP since 2001. She was a founder member of GAMP UK, and former Secretary of GAMP Europe. She currently serves as Secretary of GAMP Global Council and as part of the GAMP Data Integrity SIG Leadership Team. Charlie was awarded ISPE Member of the Year in 2019 for her volunteer activities within GAMP and for her training of Health Authority inspectors across Asia Pacific.