Sarah Taylor is a Senior Validation Specialist at PSC Biotech, where she is responsible for supporting life science companies in all aspects of the commissioning, qualification and validation (CQV) lifecycle. Sarah has consulted for a variety of life science companies across Australia over the past two years and has developed a reputation for a risk-based approach with a quality-focus and strong data integrity understanding. With nine years' experience in the pharmaceutical industry, Sarah has extensive understanding of Quality Assurance, CSV and CQV for GMP facilities, utilities, equipment, computerised systems, processes, cleaning validation, and test methods. Sarah became the Emerging Leader for the GAMP South Asia steering committee in February 2024, with her particular interest in computerised systems validation. She has since helped coordinate several webinars, as well as presented and mediated panel discussions. Sarah Taylor holds a Bachelor of Science majoring in Microbiology from the University of Otago in New Zealand where she is originally from. She moved to Melbourne in 2014 and began her career working in Quality Control laboratories in the areas of Chemistry, Microbiology and Immunochemistry, before developing an interest in validation. Sarah worked as a Senior Quality Assurance Associate for project compliance at CSL Behring during a major greenfield project and was responsible for overseeing CQV of all new facility, utilities, equipment and processes, from design through to process validation. Sarah now lives in the Blue Mountains where she enjoys rock climbing, mountain biking and trail running in her spare time.

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