Let's Talk AI: Validating AI Tools in the Life Sciences Industry: A Risk-Based Approach with Human-in-the-Loop Oversight

Artificial Intelligence is rapidly transforming the life sciences industry, offering new opportunities to improve efficiency in regulatory affairs, labeling, quality, clinical, and post-market processes. However, organizations must ensure that AI tools are appropriately validated, controlled, and governed to meet regulatory expectations while maintaining patient safety and product quality.

This presentation provides a practical framework for validating AI-enabled tools in regulated environments using a risk-based approach aligned with industry quality and compliance principles. Attendees will learn how to define intended use, assess risk, establish validation requirements, measure performance, and maintain ongoing oversight of AI systems.

A key focus of the session is the role of Human-in-the-Loop (HITL) oversight and review, demonstrating how qualified personnel should evaluate, approve, and remain accountable for AI-generated outputs.

Who Should Attend

Regulatory Affairs, Quality Assurance, Labeling, Clinical Affairs, Validation, IT, Product Development, and Compliance professionals involved in implementing or overseeing AI technologies in life sciences organizations.

Key Takeaways

• Understand how AI tools should be validated in regulated environments
• Apply a risk-based approach to AI governance and oversight
• Define effective Human-in-the-Loop review processes
• Avoid common compliance and validation pitfalls
• Establish practical controls for the responsible use of AI in life sciences operations