Adapting Project Management to the CGMP Environment

John E. Lincoln

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Why should you attend:

The U.S. FDA expects companies to manage CGMP projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD/MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not ommitted until late in the project when disaster looms? How to minimize scope creep?

What are the "lean" and "Agile" benefits and shortcomings in the cGMP environment? What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop? How to gain management support for the Milestones, Tasks, Timelines? Use the Plan as a powerful tool with FDA and ISO inspectors / auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not complex, but support the implementation of formal methods with documented, and defensible rationale. Use these tools to bring predictability to a company's product development process.  Use them to defend remediation efforts with the FDA. Use them to prove "progress against plan".

Course content:

This webinar is not a project management certification course. But it does cover basic project management tools and techniques. It addresses the three most common project management tools: 1) Gantt Chart, 2) CPM Network, and 3) PERT Network. It provides 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, and decreased product liability. It can assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Areas Covered in the Session:

  • Formal Project Management to Fulfill Common cGMP Requirements
  • "Failing Fast" Lean Project Management
  • The Three Most Common PM Tools -- Gantt, CPM, PERT + others
  • Work breakdown Structure, Milestones, Tasks; Reverse Engineering
  • Drive Success by Failing Fast
  • The Build, Measure, Learn, Re-evaluate Loop
  • A Template / Example
  • One Major, But Often Negleted, Use

Who Should Attend:

  • Senior management in Drugs, Devices, Biologics, Combination Products, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with project leadership responsibilities

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Recorded video

Recorded video session

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Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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. 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 published 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. John is a graduate of UCLA