Mr.John E. Lincoln

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

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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.

27 results Found
Live Webinar

US FDA Artificial Intelligence - Machine Learning Framework

The ability of artificial intelligence/machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and risks and has ...

  • Basic & Intermediate
  • 90 Mins
  • Mar 19, 2024
Recorded Webinar

The 510(k), IDE, Q-Sub, De Novo, and PMA Submission and Approval Process

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indic ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested fi ...

  • Basic & Intermediate
  • 90 Mins
On-Demand Webinar

The US FDA's 21 CFR Part 11: Add-on Inspections

“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...

  • Basic & Intermediate
  • 90 Mins
On-Demand Webinar

The 11 Must-Have Documents Of software Verification and Validation

The verification and validation of medical industry software are coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP®, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14 ...

  • Basic & Intermediate
  • 90 Mins
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