Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 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). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished 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 column for the Journal of Validation Technology. John is a graduate of UCLA.
DHF, DMR, DHR, and EU Technical Documentation
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR.It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technical ...
- Intermediate
- 90 Mins
- Sep 06, 2022
Design Control, Risk Management and Use / Human Factors Engineering
The U.S. FDA has required Design Control, 21 CFR 820.30 since 1996-97 as part of new product R&D. The ISO 13485:2016 7.3 requires Design and Development Planning. Both are the same, requiring the same 10 steps. Both centers around change control to minimize ...
- Basic & Intermediate
- 90 Mins
- Sep 20, 2022
Project Management for FDA-Regulated Companies
This project management training for FDA-regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for the successful development and implementation of pro ...
- Basic & Intermediate
- 60 Mins
The Validation Master Plan - The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities ar ...
- Basic & Intermediate
- 90 Mins
3D / Additive Manufacturing Printing of Medical Devices Under the US FDA
3D/ AM printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials.New terms, materials usage / application, unique device construction, all raise new metrics and quality concerns.The US FDA recognizes this ...
- Intermediate
- 60 Mins
US FDA and EU MDR Basic Medical Device Documentation Requirements
This webinar will examine the requirements for the U.S. FDA's DHF -including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements. It will evaluate the documents' differing purposes / goa ...
- Intermediate
- 60 Mins
Master Verification and Validation Planning per US FDA and EU MDR / ISO
Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evalu ...
- Intermediate
- 60 Mins
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR.It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technical ...
- Intermediate
- 90 Mins
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...
- Intermediate
- 90 Mins
CAPA Under U.S. FDA / CGMPs and EU MDR / ISO
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...
- Basic & Intermediate
- 90 Mins