This 90 minute workshop is designed for validation engineers, quality professionals, and CSV specialists who understand GMP systems validation and want a practical, defensible path forward for AI. No prior AI knowledge is required — the session opens with a plain-language primer on how large language models actually work, what makes them fundamentally different from traditional software, and why that difference matters for validation. Participants are encouraged to ask questions and share their own scenarios throughout.

The session covers: how AI systems work and where they are appearing in regulated environments; why traditional IQ/OQ/PQ is structurally incompatible with probabilistic systems; how to classify an AI system using the Autonomy vs. Design Control matrix mapped to GAMP 5 Categories and EMA Annex 22 designations; how to write a formal Context of Use statement; how to determine 21 CFR Part 11 applicability; how to define acceptance criteria, test cases, and a performance monitoring plan; and what revalidation triggers must be built into your change control process.

The hands-on component asks participants to classify a set of realistic AI system scenarios using the Autonomy vs. Design Control matrix — surfacing the most common scoping errors and grounding the framework in situations the room will recognize from their own organizations.

Participants leave with a takeaway reference guide covering the complete framework: the classification matrix, the Context of Use template, the 4-Layer AI Validation Framework, the Two-Slit Test for 21 CFR Part 11 applicability, and a monitoring plan checklist — tools they can apply immediately back at their organizations.