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Project Management for FDA-Regulated Companies - Webinar

  • ID: 4840198
  • Webinar
  • April 2020
  • Region: Global
  • 60 Minutes
  • NetZealous LLC
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Overview:
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 will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of 'progress against plan', and other activities requiring a planned documented rationale. Three of the most common tools will be discussed.

Common varients such as 'dashboards' will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate 'fire fighting' in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
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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.
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  • Senior management in Drugs, Devices, Biologics, Dietary
  • Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with project leadership responsibilities
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