John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 35 years experience in U.S. FDA-regulated industries, 21 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, CAPA systems, and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). 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 periodically writes for the Journal of Validation Technology. John is a graduate of UCLA.