Webinar on Project Management for FDA Regulated Companies – ResearchAndMarkets.com | Nation/World


The “Project Management for FDA Regulated Companies” webinar was added to ResearchAndMarkets.comoffer.

This webinar will provide valuable guidance to regulated companies in developing and implementing new Lean project management planning concepts, including some Agile principles, for new product development, responses to regulatory compliance audits, evidence of “progress against plan” and other activities requiring documented planning. reasoning.

Three of the most common tools will be covered. “Get on the rails” with a very simple approach using common PC application programs such as Excel or Word. Find out how regular use of a few simple yet powerful tools will virtually eliminate “firefighting” in a new project.

The FDA expects companies to manage projects in a formal manner, with a written plan — including regulatory requirements, design and/or change control, considering all applicable standards, and to demonstrate “progress against plan”. The EU MDD and its Notified Bodies are no different.

How can this be done from the start of a project? How to integrate Lean principles from the start of the project? What is “quick fail” in the “build, measure, learn, reassess/decide loop”? Can Agile principles integrate with FDA documentation requirements? How can a project manager or project manager ensure that critical items aren’t omitted until the end of the project when disaster looms? How do you get management support for milestones, tasks, and timelines?

Attend this training to understand how one can reduce planning uncertainty, facilitate project team communication, prevent incomplete projects when time is of the essence, reduce product liability, contribute to cost reduction efforts at company-wide, with less risk of recalls and a better bottom line.

Who should attend:

This webinar will provide invaluable assistance to all FDA-regulated companies that need an easy-to-implement, easy-to-explain, and repeatable methodology. It will provide the basic tools to help internal staff be trained in project management tools and techniques, specifically for the regulated medical product industries, for GMP compliance and EU MDD/CE marking.

It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the fields of medical devices, diagnostics, pharmaceuticals and biologics.

Employees who will benefit include:

  • Project managers
  • The senior management
  • Regulatory Affairs
  • Quality assurance/QAE
  • Production
  • R&D and Engineering

Main topics covered:

  • Meet the main requirements of CGMP / ISO; Quality diets
  • `Failing Fast` Formal Lean Project Management
  • The three most common tools – Gantt, CPM, PERT
  • Work breakdown structure, milestones, tasks
  • Drive success or failure quickly; Fast Cycle/Agile Principles
  • The Build, Measure, Learn, Reassess Loop
  • Example: A suggested new product model
  • A major use, but often overlooked


Consultant John E. Lincoln has successfully designed and authored over 50 ISO 14971 compliant risk management files/reports, including FMECA and FTA analyses, many in response to FDA Observation 483, which have then successfully passed FDA submission audit or review, and described in peer-reviewed technical articles and workshops, worldwide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups from Fortune 100 companies including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. John sits on the editorial and review boards of MDDI Magazine and the Journal of cGMP.

For more information on this webinar, visit https://www.researchandmarkets.com/r/letf45

Show source version on businesswire.com:https://www.businesswire.com/news/home/20220630005664/en/

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SOURCE: Research and Markets

Copyright BusinessWire 2022.

PUBLISHED: 06/30/2022 10:49 AM/DISC: 06/30/2022 10:49 AM


Copyright BusinessWire 2022.