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Validity : 16th Nov'24 to 26th Nov'24
Project Management for FDA-Regulated Companies
- Meet key requirements of the CGMPs/ISO; Quality Plans
- "Failing Fast" Formal Lean Project Management
- The Three Most Common Tools - Gantt, CPM, PERT
- Work breakdown Structure, Milestones, Tasks
- Drive Success or Failure Fast; Fast Cycle / Agile Principles
- The Build, Measure, Learn, Re-evaluate Loop
- Example: A Suggested New Product Template
- One Major, But Often Neglected, Use
Overview of the webinar
This project management training for FDA-regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for the successful development and implementation of project management planning.
Who should attend?
This webinar will 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 to be 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
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 omitted until late in the project when disaster looms? How do gain management support for the Milestones, Tasks, Timelines?
This webinar will provide valuable guidance to regulated companies in the development and implementation of new Lean Project Management Planning concepts including some Agile principles, for new product development, 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. Learn how regular use of a few simple but powerful tools will virtually eliminate "firefighting" in a new project.
Attend this training to understand how one can reduce scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.