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.

21 results Found
Live Webinar

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time. It ...

  • Intermediate
  • 60 Mins
  • Dec 13, 2021
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
On-Demand Webinar

Preparing a 21 CFR Part 11 QMS Software Validation Protocol

Review a company's software and Part 11 Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and how it addresses Part 11. Evaluating its elements against ISO 14971 and ICH Q9 for hazard analysi ...

  • Intermediate
  • 90 Mins
On-Demand Webinar

Implementing the New Usability Engineering Standard – IEC 62366-1 and IEC/TR 62366-2: Guidance on Application

Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.This usability engineering (huma ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Verification vs. Validation – Product¸ Process or Equipment, Software and QMS

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, evaluating i ...

  • Basic & Intermediate
  • 90 Mins