Artificial Intelligence is rapidly becoming part of everyday work in the life sciences industry. Employees are using ChatGPT, Copilot, Gemini, enterprise AI platforms and other tools to draft emails, summarize meetings, analyze information, prepare reports and communicate with colleagues, vendors, investigators and regulatory teams.

But in an FDA-regulated environment, using AI to create or process communications is not simply a productivity decision—it can become a compliance, data integrity, confidentiality and inspection-readiness issue.

AI-generated communications may contain inaccurate information, unsupported regulatory interpretations, hallucinated references, omitted context or inappropriate disclosures of confidential information. At the same time, organizations must consider how AI-generated or AI-assisted communications should be reviewed, controlled, documented, retained and governed. FDA’s evolving AI framework emphasizes a risk-based approach, clear context of use, human-centric design, data governance, documentation, performance assessment and lifecycle management.

This practical webinar will examine five critical best practices that FDA-regulated organizations should consider when using AI for business and regulatory communications.

Why Should You Attend?

Email and electronic communications already play a critical role in FDA-regulated operations, providing evidence of decisions, activities, reporting and interactions across product development, clinical research, quality, regulatory affairs, pharmacovigilance and manufacturing. The introduction of generative AI adds another layer of complexity.

What happens when you ask AI to draft a response to an FDA question? Can confidential clinical information be entered into a public AI platform? Should an AI-generated meeting summary be treated differently from a human-written record? Who reviews an AI-generated regulatory statement? What happens when an AI tool produces an incorrect FDA citation? This webinar will help organizations address these practical questions and establish a more controlled approach to AI-enabled communications.

Five Best Practices Covered :

• Protect Confidential and Regulated Information When Using AI
  Learn what FDA-regulated, proprietary, clinical, and sensitive information should—and should not—be entered into AI tools.
• Verify and Control AI-Generated Communications
  Understand how to identify hallucinations, inaccurate regulatory statements, incorrect citations, missing context, and other risks before AI-generated content is used or shared.
• Manage AI-Assisted Communications as Reliable Electronic Records
  Explore documentation, traceability, retention, audit trails, and data-integrity considerations when AI creates, summarizes, or modifies regulated communications.
• Establish Risk-Based AI Governance and Human Oversight
  Learn how to evaluate AI tools based on intended use, risk, performance, validation/assurance, vendor controls, change management, and appropriate human review.
• Use AI to Strengthen Communication Compliance and Inspection Readiness
  Discover how AI can potentially help identify data leakage, inappropriate communications, missing documentation, inconsistent statements, and other compliance risks.

What Will You Learn ?

By attending this webinar, you will gain practical insights into:

• Establishing appropriate AI-use policies for regulated communications
• Identifying high-risk and low-risk AI communication activities
• Managing confidential and regulated information
• Reviewing and verifying AI-generated regulatory content
• Maintaining human oversight and accountability
• Addressing electronic records and documentation considerations
• Assessing AI tools before incorporating them into regulated workflows
• Reducing hallucination, data-integrity and communication risks
• Preparing for potential FDA inspection questions involving AI-assisted work
• Using AI responsibly while maintaining regulatory control

Who Will Benefit?

This webinar is intended for professionals across Regulatory Affairs, Quality Assurance, Clinical Research, Pharmacovigilance, Medical Affairs, Compliance, Information Technology, Data Management, and senior management who seek to understand the responsible, compliant, and effective use of AI in FDA-regulated communications.

Whether your organization is already using generative AI or is developing its AI governance strategy, this session will provide a practical framework for adopting AI without losing control of compliance, data integrity and regulatory accountability.

AI is changing how regulated organizations communicate and work. The organizations that benefit most will not necessarily be those that use AI the most—but those that establish the right controls around its use. Join this webinar to understand how to use AI more effectively while keeping FDA compliance, data integrity and inspection readiness at the center of your communication strategy.