Understanding AI/ML in GMP: Validation, Risk, and Real-World Applications

Presented Tuesday, March 11, 2025

Artificial intelligence (AI) and machine learning (ML) are transforming the pharmaceutical industry, but their implementation in Good Manufacturing Practice (GMP) environments requires careful validation and risk management. This session provided a structured approach to understanding AI/ML in GMP, starting with foundational concepts and real-world examples, followed by an in-depth look at how machine learning works, its validation strategies, and a case study on risk management.

Areas covered:

• Real-world examples of AI/ML applications in GMP environments
• A fundamental introduction to machine learning and how it works
• Key strategies for validating ML models in compliance with GMP regulations
• A case study on risk management in AI/ML implementation