John English

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John T English LLC
Principal
John English, HCCP, is a Principal/Consultant in a private practice and has over 25 years of experience in review and validation of US FDA–regulated computer systems, both on-site and remotely. He is an expert in 21 CFR Part 11, data integrity, cloud and virtualization issues, analysis of FDA 483, and warning letters. John has served on the FDA-PDA Data Integrity Task Force and is a current member of GAMP Special Interest Group on AI and ML. He holds master’s degrees from the University of Connecticut and Seton Hall University (SHU) and a certifi cate in US healthcare compliance from the SHU School of Law. He joined ISPE in 2002.