JOHN E LINCOLN
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are independent consultants. 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.
September 08 2021
01 : 00 PM EST
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Exi..
October 12 2021
01 : 00 PM EST
This webinar will discuss the 9 stages of use engineering required by IEC 62366-1. It also briefly reviews IEC 62366-1 / IEC/TR 62366-2 - Medical Devices package, which provides assistance with the proper use of medical devices as it pertains to human risk factors.The standard specifies safety related processes to analyze, develop, and evaluate the usability of medical devices and is applicable ..
How can companies address the U.S. FDA’s tougher stance and product, process, and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, proc..