AI in Pharmaceutical Quality Management Systems

Summary

Many pharmaceutical organisations are already exploring AI technologies, yet struggle to move from isolated experimentation and “Shadow AI” usage to structured, scalable, and compliant implementation. Few have established the governance structures, compliance frameworks, and lifecycle controls required to integrate AI responsibly within GxP-regulated environments.

This two-day course gives you a practical, compliance-focused introduction to AI governance and the controlled implementation of Artificial Intelligence (AI) within pharmaceutical quality systems (PQS).

You will gain insight into how AI technologies can support quality, regulatory, manufacturing, and operational processes while maintaining compliance with EU GMP requirements, ICH guidelines, 21 CFR Parts 210 and 211, data integrity principles, and emerging AI governance frameworks such as the EU AI Act.

The course also covers the regulatory expectations outlined in EudraLex Volume 4, Annex 11, for computerised systems and electronic data management, as well as the emerging Annex 22 on Artificial Intelligence. This gives you a structured understanding of how AI can be governed, validated, and integrated into GxP-regulated environments in a compliant, risk-based manner.

The course combines strategic governance perspectives, including lifecycle management, human oversight, monitoring, and change management expectations for AI-enabled solutions, with practical implementation examples and workshops.

You will learn to identify valuable AI use cases, establish governance frameworks, assess risks, and integrate AI solutions into existing quality processes in a controlled, traceable manner.

The focus is not on programming AI models, but on enabling you and your organisation to adopt AI responsibly, effectively, and compliantly.

Keywords

• AI
• GMP
• GxP
• EU AI Act
• Pharmaceutical Quality Systems (PQS)
• Annex 11
• Annex 22
• EudraLex Volume 4