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Home  >  Speakers  >  John E. Lincoln
John E. Lincoln

John E. Lincoln

Director, Consultant | Los Angeles, California    United States of America
Healthcare Technology, Quality Management
Quality Management, Healthcare Technology,...More
Spoken at 22 events

Biography :

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 32 years experience in U.S. FDA-regulated industries, 18 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.

He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring medical device / CGMP column for the Journal of Validation Technology. John is a graduate of UCLA.

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Specialties

Healthcare Technology, Quality Management

Interested Topics

Quality Management, Healthcare Technology, Quality Assurance, Medical Devices, Quality System, Design Control, Quality Control, Research and Development, Quality Auditing

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Languages

English

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