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John E Lincoln

Consultant, J. E. Lincoln and Associates LLC

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.



  •  Wednesday, March 20, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

  •  Wednesday, April 3, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes

  •  Tuesday, April 23, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
The Most Serious FDA 483s - How to Avoid them

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.





  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents,

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR.

  • Recorded
  • View Anytime
  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.