Overview
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.
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 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".
Webinar Takeaway
- Why formal Project Management
- The three most common tools
- ChatGPT / AI - Tools and Dangers
- Gantt, CPM, PERT
- Simple construction techniques
- Work breakdown Structure, Milestones, Tasks
- Effectiveness - Determining and Monitoring
- The "New Product Example"
- The "Remediation Example"
- How to compile
Who Will Benefit
- Senior Management in Pharmaceuticals
- QA / RA
- AI Software Programming, Documentation, Testing Teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants
Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is a leading FDA compliance and regulatory affairs consultant with over 41 years of experience in FDA-regulated industries and 27 years as Principal of J. E. Lincoln and Associates LLC. He is recognized globally for his expertise in cGMP compliance, quality assurance, and medical device validation.
Throughout his career, John has partnered with pharmaceutical, biotechnology, and medical device companies — from startups to Fortune 100 organizations — across the U.S., Canada, Mexico, Europe (France, Germany, Sweden), and Asia (China, Taiwan).
His consulting specialties include:
- FDA Quality System Regulation (QSR) compliance and QMS remediation
- Process, product, and software validation (including 21 CFR Part 11 systems)
- ISO 13485 and ISO 14971 risk management implementation
- Design Control, Design History File (DHF), and Technical File development
- Regulatory submissions, including FDA 510(k) filings and responses to FDA audit observations
John has held leadership roles in Manufacturing Engineering, Quality Assurance, Quality Engineering, Regulatory Affairs, and R&D, progressing to Director and Vice President levels.
As a recognized FDA industry expert and speaker, he has:
- Authored peer-reviewed journal articles and five chapters in the RAPS textbook on validation
- Delivered global workshops, seminars, and webinars on FDA cGMP, validation, and risk management
- Helped hundreds of organizations achieve FDA and ISO compliance through practical, hands-on training
