AI validation training your inspectors would approve of
Your organisation is deploying AI faster than your validation approach can absorb it. This programme gives your QA, validation and IT teams a defensible method: classify, risk-tier, validate, monitor. Taught from live deployments, not slideware.
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, on-site or online, 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: A Practitioner's Guide, rated 4.8 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.
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Questions teams ask
What formats does the AI validation training run in?
Three formats: an executive orientation for leadership teams that need the strategic frame, a one-day practitioner programme per batch of up to 30, and a two-day deep programme that adds supervised work on the client's own use cases and evidence packs. All run on-site or online.
Do participants need AI or data science background?
No. The programme is written for quality, validation and IT professionals who know CSV and GxP. The AI concepts arrive in validation language: intended use, risk, evidence, change control and monitoring, with the technology explained exactly as deep as the validation decision needs.
What does the training cost?
It is quoted per engagement based on format, batch count and location, usually the same day you ask. Each participant can also receive the book and its templates as part of the programme; that option goes into the quote.
Bring the AI validation training in-house
Tell me your use cases, dates and participant numbers, and you will have a quote the same day.
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