Integrating AI and ChatGPT into Project Management for Better FDA Compliance

In the highly regulated world of pharmaceuticals, biotechnology, and medical devices, project managers face constant pressure to deliver results on time while ensuring strict adherence to FDA compliance requirements.

From Good Manufacturing Practice (GMP) to Good Clinical Practice (GCP) and Quality System Regulations (QSR), every phase of a project must meet exacting standards. This demands precise documentation, strong cross-functional coordination, and proactive risk management. However, the administrative workload tied to regulatory compliance often slows down progress and increases the risk of errors. Artificial intelligence (AI) tools like ChatGPT are now offering a solution-helping project teams streamline workflows, improve documentation accuracy, and support regulatory readiness.

This 60-minute webinar, “Integrating AI and ChatGPT into Project Management for Better FDA Compliance,” is designed to show how project managers can responsibly integrate AI into their day-to-day work to enhance both productivity and compliance. ChatGPT, a conversational AI developed by OpenAI, can assist with drafting project documents, summarizing meetings, automating routine communications, and generating audit-ready content. These capabilities reduce time spent on repetitive tasks, giving project teams more bandwidth to focus on risk mitigation, stakeholder engagement, and strategic planning.

The session begins by reviewing common FDA compliance challenges in project settings, such as incomplete documentation, missed deadlines, and inconsistent communication. We then explore how ChatGPT can help address these pain points throughout the project lifecycle-from initiation to execution to closure. For example, during project initiation, ChatGPT can draft charters, schedules, and resource justifications. In execution, it can support real-time updates, CAPA documentation, and team coordination. At the closure stage, it can assist in generating final reports, audit summaries, and lessons learned documents-all aligned with regulatory expectations.

While AI offers many benefits, using it in a regulated environment requires careful oversight. The webinar covers essential considerations such as validation of AI outputs, maintaining data privacy, and documenting AI’s role in decision-making processes. We’ll also discuss how to create audit trails for AI-assisted work and ensure human oversight remains in place. Attendees will learn practical strategies for using ChatGPT within a GxP framework without compromising compliance integrity.

By the end of the session, participants will have a clear understanding of how ChatGPT and other AI tools can be used to improve project execution in FDA-regulated environments. They’ll gain actionable insights, real-world examples, and best practices for responsibly integrating AI into their workflows. This webinar is ideal for project managers, quality professionals, and regulatory teams looking to enhance their efficiency while maintaining strong compliance foundations.

Why you should Attend:
Participants should attend this webinar to gain a practical, forward-looking understanding of how AI-specifically ChatGPT-can be used to streamline project management tasks while strengthening FDA compliance. In an industry where regulatory missteps can lead to costly delays, inspection findings, or product recalls, learning to responsibly integrate AI into documentation, communication, and risk tracking offers a competitive advantage.

This session goes beyond theory, offering real-world use cases, best practices, and compliance-aware strategies that professionals can apply immediately. Whether you're a project manager, quality specialist, or regulatory affairs professional, this webinar will equip you with the tools and confidence to embrace AI while maintaining full alignment with FDA expectations.

Areas Covered in the Session:

• Section 1: Welcome and Introduction (5 minutes)
• Importance of FDA compliance in life sciences project management
• Brief overview of AI and ChatGPT capabilities
• Key learning outcomes of the session
• Section 2: FDA Compliance - What Project Managers Need to Know
• Overview of FDA-regulated environments (GMP, GCP, QSR)
• Project management challenges in compliance (documentation, traceability, audits)
• Common pitfalls in FDA-regulated projects
• Importance of accurate, timely, and traceable decision-making
• Section 3: The Role of AI and ChatGPT in Project Management
• Introduction to AI and large language models (LLMs) like ChatGPT
• Benefits of AI in regulated project environments
• Use cases: task automation, document generation, regulatory intelligence
• Risk considerations: validation, data privacy, and control
• Sction 4: Practical Use Cases - ChatGPT in FDA-Driven Projects
• Drafting SOPs, protocols, and regulatory documents using AI
• Automating status reports and team updates
• Creating project schedules with embedded compliance checkpoints
• Real-time Q&A, brainstorming, and meeting summaries with ChatGPT
• Use of AI in CAPA management, risk assessments, and audit prep
• Section 5: Governance, Validation, and Ethical Use of AI in Compliance Projects
• GxP and AI: understanding the limitations and regulatory expectations
• Validation of AI tools in compliance-sensitive workflows
• Documenting AI usage for audit trails
• Ethical use of AI in decision-making and human oversight
• Section 6: Q&A and Closing Remarks (10 minutes)
• Live audience questions and practical clarifications
• Key takeaways and best practices
• Resources for further exploration (e.g., FDA guidance, AI in life sciences)

• Project Manager - Life Sciences / Regulatory Projects
• Regulatory Affairs Specialist / Manager
• Quality Assurance Manager / Specialist
• Compliance Officer / Compliance Manager
• Clinical Project Manager / Clinical Trial Manager
• GMP/GCP Compliance Specialist
• Document Control Manager
• Validation Specialist
• Technical Writer - Regulatory Submissions
• R&D Program Manager
• Medical Device Project Manager
• Pharmaceutical Operations Manager
• AI and Digital Transformation Lead - Life Sciences
• Quality Systems Coordinator
• Process Improvement Specialist
• Inspection Readiness Coordinator
• Training and Development Manager - Compliance Training
• CAPA Manager / Risk Management Lead
• IT Systems Analyst (Supporting Compliance Systems)
• Clinical Data Manager (Involved in Regulatory Documentation)