John E. Lincoln

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years experience including 21 years as a full time consultant, serving U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100 in the U.S., Mexico, Canada, France, Germany, China, and Taiwan. He specializes in medical device CGMPs / systems / SOPs, product to market, defect and cycle time reduction, equipment / process / product / software documentation / validation, quality/regulatory management, product risk / ISO 14971, product clearance and regulatory issues resolution. He’s held assignments as VP R&D, Director of QA/RA, senior QA engineer, senior manufacturing engineer, working for such companies as Abbott Laboratories and Mallinckrodt Medical. Additional experience has been in government (civil and military), aerospace and electronics industries. He has published numerous peer-reviewed articles on culture change, training, biohazards, quality, regulatory affairs, CAPA, and validation. He conducts webinars, workshops and training worldwide. He has a BA from UCLA.


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