John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers

The bluEPrint by Executive Platforms

At the 2024 edition of the Biomanufacturing World Summit series we sat down with John H. Adams, Jr., Spark Therapeutics’ Senior Director, Validation, to talk about Computer Software Assurance in the Life Sciences. John has been doing Computer Systems Validation (CSV) for decades as a regulatory requirement, so when talk of a risk-based Computer Software Assurance (CSA) requirement started making the rounds, he was interested to understand the differences so he could best stay ahead of the compliance curve and ensure his best practices were not out of step with expectations. In this episode, John walks us through where the conversation between industry and regulators currently stands, what validation professionals should already be doing, what they should continue to do, what they should confirm they are doing correctly, and what they should prepare themselves for if and when current guidance becomes new regulations. For everyone in the Life Sciences who cares about the compliance of manufacturing systems, give this episode a listen!
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John H. Adams, Jr.
Senior Director, Validation
Spark Therapeutics

In his current role as the Senior Director of Validation at Spark, John leverages over 24 years of expertise in the compliance and validation of enterprise computer systems, applications, and equipment regulated by the FDA and EU. John is a compliance and validation thought leader and has a deep understanding of 21 CFR Parts 210, 211, 606, 820, 11, and Annex 11. John’s experience spans a variety of analytical systems, including HPLCs and spectrophotometers, as well as computer systems such as ERP, LIMS, EDMS, EMS, PCS, and DCS, serving major pharmaceutical, medical device, and blood management companies. Before joining Spark in May of 2015, his career included roles at Pfizer, AstraZeneca, TEVA, Smith & Nephew, GE Healthcare, DSM, Haemonetics, and the American Red Cross, where he has consistently ensured compliance with predicate rules, 21 CFR Part 11, and GAMP 5 guidance. John holds a Bachelor of Science degree in Computer Information Systems from the Florida Institute of Technology.