Charlie Wakeham is the founder and Director of WakeUp to Quality, a consultancy company specializing in computerized systems validation, data integrity and data governance, QMS improvements, and training. Charlie’s 25+ years in the Life Sciences industry includes roles in process engineering, project management and systems R&D at Pall Life Sciences (now Cytiva) in the UK, as the APAC GxP Compliance Manager setting up and managing validation services at Waters Corporation, and as the Global Head of Quality and Compliance at Magentus in Australia. Charlie has delivered presentations, training sessions, and workshops at conferences worldwide for over two decades, and she was the sole industry presenter at the PIC/S Inspectors Seminar held in Taiwan in 2017. Charlie has been a passionate ISPE GAMP® volunteer since the early 2000s. She is currently Chair of the ISPE GAMP Global Steering Committee, founder and Chair of ISPE GAMP South Asia Community of Practice, and a leader of the GAMP CSA Special Interest Group. She has contributed to or led the creation of nine GAMP guides, including the Second Edition of GAMP 5 published in 2022. Charlie was awarded the Max Seales Yonker ISPE Member of the Year in 2019 for her volunteer activities within GAMP and for her training of Health Authority inspectors across Asia Pacific. https://au.linkedin.com/in/charliewakeham