Speaker Profile


John E Lincoln

Consultant, Medical device and Regulatory affairs

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, June 20, 2018
  • 08:00 AM PDT | 11:00 AM EDT,
  • 3 Hours
  • ¤290.00
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.

  •  Wednesday, June 27, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

  •  Wednesday, July 25, 2018
  • 08:00 AM PDT | 11:00 PM EDT,
  • 3 Hours
  • ¤290.00
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. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

  •  Wednesday, August 15, 2018
  • 08:00 AM PDT | 11:00 AM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on Verification vs Validation-Product, Process or Equipment and QMS Software

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 or ICH Q9, hazard analysis / risk management, allows development of meaningful product validations. Clear up definition confusion with suggested "working definitions".

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
The 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
  • ¤189.00
Compiling the Design History File, and Technical File, Design Dossier

This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

  • Recorded
  • View Anytime
  • ¤189.00
Change Control - Key to Successful cGMP Compliance

There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

  • Recorded
  • View Anytime
  • ¤189.00
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. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

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NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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