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Project Management for FDA-Mandated Activities

Recorded Session | John E. Lincoln | From: May 22, 2023 - To: Dec 31, 2023
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Course Description

This webinar will provide valuable guidance to regulated companies in the development and implementation of Project Management Planning concepts including some Lean / Agile principles, for new product development, Design Control, Risk Management, Human Factors, 510(k)s, regulatory compliance audit responses, proof of "progress against the plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. "Hit the ground running" with one very simple approach using common Excel- or Word-type PC applications programs. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Incorporate lean principles into project management. Regular use can contribute greatly to the reduction of scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease product liability, and assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Areas Covered:-

  • Meet key requirements of the CGMPs/ISO; Quality Plans
  • "Failing Fast" Formal Lean Project Management


Project Management can be a key to company success in a regulated industry, by incorporating a written Plan, using basic lean principles, while addressing FDA / CGMP requirements.

Why Should You Attend:-

The FDA expects companies to manage projects formally, with a written plan to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against the plan". The EU MDD and their notified bodies are no different. How can this be done from a project`s inception? How can lean principles be incorporated from project inception? What is "failing fast" in the "build, measure, learn, re-evaluate/decide loop"? Can Agile principles mesh with FDA`s documentation requirements? How can a Project Leader or Project Manager ensure critical elements are not committed until late in the project when disaster looms? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use it to document cGMP remediation activities. Use as a component of a Quality Plan, for any size or type of regulatory project. Growing high-profile field problems indicate that much project management is poor or nonexistent. Buy up-front time for proper project planning. Simple techniques using formal methods with documented, and defensible rationale.  Bring predictability to the company`s product development process. Document and defend your remediation efforts with the FDA -- prove "progress against the plan".

Who Will Benefit:-

This webinar is not a project management certification course. It`s a project management tool for the CGMP compliance course. Its purpose is to provide valuable 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 assist in-house personnel in being trained in project management tools and techniques, targeted specifically to the regulated medical products industries, under cGMP and EU MDD/CE-marking compliance. 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 Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Project Managers
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering

All personnel tasked with any project management responsibilities, and those who soon hope to be.