AI validation training for GxP teams, taught by the author of Validating AI in GxP

What is AI validation training?

AI validation training teaches regulated teams how to take AI, ML and GenAI systems through a validation lifecycle an inspector will accept: defining intended use, classifying the system into a risk tier, sizing the evidence to that tier, and monitoring drift after go-live. The regulatory spine is Draft Annex 22, the EU AI Act, 21 CFR Part 11, Annex 11 and FDA CSA, held together so the team sees one method rather than five documents.

How the programme runs

One or two working days, per batch of up to 30, in person at your site, up to CIO, CQO and Global Head of Quality level. The core is the four-tier risk model from Validating AI in GxP, worked on the client's own AI use cases: participants classify their real systems, draft intended-use statements, and walk an evidence pack for one tier. Executive orientation formats run shorter and sit at leadership level; practitioner formats go deep into protocols and test strategy.

Corporate programmes on this material are currently running or quoted with several of India's largest pharma companies and global consultancies, and the executive orientation format runs for leadership teams that need the strategic frame first.

Who teaches it

Sachin Bhandari wrote the book on this: Validating AI in GxP Environments: A Practitioner's Handbook, rated 4.7 out of 5 by its first readers. He contributes to the EU GMP Annex 22 (AI) industry review, sits on the Global GAMP Steering Committee, and has deployed and validated real AI in live GxP quality operations. The training carries that practice: what worked, what failed, and what the inspector actually asked.

What your team takes away

• The four-tier AI risk model, applied to your own use cases in the room.
• Intended-use and evidence patterns per tier, ready to reuse.
• A drift and monitoring rhythm that keeps models valid after go-live.
• The Annex 22 and EU AI Act readiness picture, translated to a work plan.

Who is a good trainer for AI validation in GxP?

Choose someone who has validated AI in live GxP use and defended it to an inspector. Sachin Bhandari validated 20+ AI applications in live GxP use (deviations, queries and CAPA support among them), and took 9 of them through health-authority inspection, 6 FDA and 3 MHRA, with zero compliance observations. He wrote Validating AI in GxP.

What does an AI validation training course cover?

The 8-hour day starts with why a CSV instinct fails on AI, then governance before validation, the four-tier risk model and who signs at each tier, intended use and the human-in-the-loop boundary, where Annex 22, CSA, Part 11 and the AI Act apply, training data, the evidence that earns the validated state, drift monitoring and inspection readiness.

Who should attend AI validation training?

QA, validation, CSV and IT professionals who will approve, test or own AI systems in GxP, and the system owners who bring the use cases. Participants need no data science background, because the AI concepts arrive in validation language. Leadership teams that need the strategic frame first can start with the shorter executive orientation.

When do you need AI validation consulting as well as training?

Training gives your team the method. Bring in AI validation consulting when you need the governance set up, a live use case validated to its risk tier, or an evidence pack checked before an inspection. Training first and consulting on the first high-risk use case keeps the method and the evidence in one pair of hands.

Questions teams ask