Praful Mehta
Director
About Praful Mehta
Praful Mehta specializes in the areas of Training, Developing, and Auditing for Quality Management Systems (QMS) against ISO 13485-2016 and ISO 9001-2015 for Medical Device, Pharma Industries and Chemical Manufacturers. He has applied his skills worldwide to enhance his experience, leadership, management, development, and knowledge of the cGMP. In the past 40 years, Praful has trained over 7000 “students” against all the versions of ISO 9001 & ISO 13485 requirements. He has conducted over 600 QMS Audits against ISO 13485, ISO 9001, ISO 17025, and FDA/QSR/21 CFR 820 US Federal Regulation for Medical Device Industries primarily for companies like, J & J, Bausch & Lomb, Illumina, Intuitive Surgical Inc., Ontario Plastics, Kodak, Philips Healthcare, Flextronics (in China) and many others.
Praful is an Exemplar Global Certified QMS Lead Auditor, # 1758, ASQ Certified CQE and CQA. He has acquired M.S. in Chemistry from the University in Connecticut. He is the author of the book, “ISO 9000 Questionnaire and Registration Guidelines” published through ASQ in 1996. He has lectured on QMS, cGMP, Supplier Quality and Audits at the National and International levels in Quality Conferences.