Project Management Under the CGMPs for Non-Project Managers

John E. Lincoln

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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. Use Project Management Tools, including Lean and Agile principles, for realistic and cGMP-compliant management and documentation of a project. 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.  

Why Should You Attend?

The FDA expects companies to manage projects formally – by means of a “plan”, 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 omitted 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 auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale.  Use these tools to bring predictability to your company's product development process.  Use them to defend your remediation efforts with the FDA, other inspectors / auditors. Use them to prove "progress against plan". 

Three of the most common tools will be discussed.  Common varients such as "dashboards"  will also be presented. A very simple approach using common spreadsheet- or word processing-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.  Each successful implementation also provides a template to simplify the next similar project’s “plan”.


Learning Objectives:

  • An overview of the three most common project management tools, the Gantt Chart, CPM, and PERT
  • Actual examples
  • Advantages and disadvantages of each tool
  • Key CGMP activities requiring use of project management tools
  • Work Breakdown Structure and “Reverse Engineering”
  • Suggested common CGMP Milestones and Tasks
  • Metrics you must consider and methods to implement
  • Understand some of the challenge

Areas Covered in the Webinar:

  • 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, Reverse Engineering, Milestones, Tasks
  • Templates / Examples
  • One Major,  But Often Neglected, Use
  • Avoidance of Warning Letters and common FDA 483 Observations
  • Challenges

Who Will Benefit:

  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Quality Control Professionals
  • Supply Chain Personnel
  • Hazard Analysis and Risk Management Personnel
  • Complaint Handling Professionals
  • Purchasing Personnel
  • R&D Staff
  • Manufacturing Engineers
  • Process Development Personnel
  • Operations Personnel
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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

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