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Project Management Tools for Regulatory Compliance
- 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
- Templates / Examples of Typical Regulatory Applications
- One Major, But Often Neglected, Use
Overview of the webinar
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. 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. 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, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
Who should attend?
- Senior management
- R&D
- QA / RA
- Middle management
- Manufacturing
- Operations
- Engineering
- Marketing
Why should you attend?
The FDA expects companies to manage projects formally -to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD 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 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.Use them to prove "progress against plan" and save yourself a Warning Letter .
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.