Tuesday, March 11, 2025
8:30 AM PST / 11:30 AM EST

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 will provide 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
Speakers:

Dr. Ulrich Kollisch

Partner with GxP-CC

Dr. Jennifer Roebber

Senior Consultant with GxP-CC