Biography:

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years of experience in U.S. FDA-regulated industries, 26 as an independent consultant. John has worked with companies from start-ups to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process/product/equipment including QMS and software validations, ISO 14971 product risk management, human factors files/reports, Design History Files, and Technical documentation. He's held positions in Engineering, QA, QAE, and RA, to Director and VP (R & R&D). In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles and book chapters (RAPS) in peer-reviewed journals and conducted workshops and webinars worldwide. John is a graduate of UCLA.