Mr.John E. Lincoln

Area Of Expertise : CAPA, DHF,DMR
40 Years Of Experience
Training Industry : Human Resources

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.

24 results Found
Live Webinar

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
Live Webinar

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
On-Demand Webinar

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
Recorded Webinar

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
Recorded Webinar

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
Free Webinar

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
Free Webinar

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
Free Webinar

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
Recorded Webinar

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
Free Webinar

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