This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance 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. One very simple approach using common Excel-or Word-type PC applications programs that can be used immediately. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project.
ChatGPT / AI assistance come with some uniques problems / dangers which must be addressed. 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.
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 MDR and their notified bodies are no different.
How can this be done from a project's inception? Can ChatGPT / AI be used to facilitate the process? 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? How to conclude a project "on time" and "within budget"? 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. What are the advantages / disadvantages of using Chat GBT (et al) / AI to assist in project management? Where best used? Current problems / dangers? Buy up-front time for proper project planning.
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".
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups 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, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.