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ChatGPT / AI and Project Management for FDA-Regulated Companies
- Gantt Chart
- CPM Chart
- Pert Chart
- Advantages and disadvantages of each
- Milestones, tasks – the WBS
- AI / Chatbot helps and hinderances
- Project Management in common regulatory projects - examples
Overview of the webinar
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Design Control, Risk Management, Human Factors, 510(k)s, 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. "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 reduction of 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.
Who should attend?
- Top management
- R&D
- Engineering
- Marketing
- Regulatory Affairs
- QA
- Manufacturing
- Operations
- Operators
- Staff
Why should you attend?
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. 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 plan". The EU MDD and their notified bodies are no different. How can this be done from a project's inception CAN current AI tools such as ChatGBT, Copilot, Claude, Gemini, et al, assist; and what are the pitfalls? 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 to gain management support for the Milestones, Tasks, 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 non-existent. Use 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 plan".
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.