Charlie Wakeham has more than 20 years of industry experience developing and validating computerized systems for regulated production and laboratory environments. An active ISPE GAMP® member since 1999, she serves on the GAMP Data Integrity Leadership Team and GAMP Global Council. Charlie has contributed content to multiple GAMP Good Practice Guides and co-led the production of A Risk-Based Approach to Testing of GxP Systems (Second edition), the Data Integrity – Key Concepts RDI Guide and the Data Integrity for Manufacturing Records RDI Guide. Her volunteer efforts within GAMP have led her to present at many conferences globally including the 2017 PIC/S Seminar in Taipei, and to deliver training to inspectors from numerous regulatory agencies. Charlie is Waters Corporation's Regional CSV Consultant, where she works directly with Waters' customers in the Asia Pacific region to provide efficient, practical assistance with the validation of their laboratory Informatics computerized systems.