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David Margetts
Factorytalk Co., Ltd.
CEO
David Margetts is the CEO of Factorytalk, and an advisor, consultant, and technical expert in the areas of compliance and information technology. David’s background and experience span a wide range of IT solutions for GxP applications, from shop floor systems to the corporate level in the pharmaceutical, biotechnology, and ATMP industries. Before moving to Asia in 2004 to help start Factorytalk, he worked in engineering and validation for Industrial Technology Systems Ltd., in engineering roles for AstraZeneca PLC ,and he is the former Managing Director of Asia for Werum/Koerber Pharma. David is active in ISPE as a certified trainer for computer validation and in Pharma 4.0™ and its Validation 4.0 group. He is both responsible to lead the company and manage critical client assignments for large Pharma MNCs and leading regional manufactures. He has been an ISPE member since 2004.
An interview with Shin Kawamata of Japan’s Foundation for Biomedical Research and Innovation (FBRI) highlights exciting work to move cell therapy toward reliable and scalable commercialization.
Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when applied with digitization, can verify processes in scale-up and technology transfer, and why blend and content uniformity matter for tablet integrity.
A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as