In July 2025, Draft EU GMP Annex-22 was published, providing guidelines developed by the European Union as part of its Good Manufacturing Practice (GMP) framework. This new annex is specifically dedicated to the use of Artificial Intelligence (AI) and machine learning (ML) in life sciences manufacturing environments.
Think of it this way: If the explosive growth of AI and its rush to adoption feels like the "wild west", then Annex 22 is the new "sheriff" in town providing oversight for GMP-regulated environments.
Join us to hear from a panel of industry experts as they break down Annex 22 and considerations in scaling AI/ML deployments across the manufacturing network.
In this webinar, you will learn:
- Overview of Annex 22’s scope, structure, and where it fits in the broader regulatory framework.
- Practical guidance to align systems, SOPs, and validation with Annex 22.
- Clarity on what's permitted—static, deterministic AI models only; dynamic models, generative AI, and LLMs are excluded in critical functions.(Public Health)
- Strategies to manage test‑data independence, model traceability, and governance.
- Expert insights on avoiding non‑compliance risk while leveraging AI for operational excellence.
- Considerations in doing all the above – at scale.
Featured Speakers
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