Biography:

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up 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 and human factors files/reports, Design History Files, Technical documentation.  He's held positions in  Engineering, QA, QAE, RA, 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.   John is a graduate of UCLA.