Book a training for your team
Your AI tools are live and your systems are moving to CSA. The question an inspector will ask is whether your team can defend the decisions. Three programmes, taught live on your own systems, private to your organisation, for a batch of up to 30 participants.
India pricing shown · delivered worldwide, on site or online · international pricing on requestDelivered worldwide, on site or online · pricing is quoted per country · request a proposal below
Every session is taught live by Sachin Bhandari, author of Validating AI in GxP, draft Annex 22 industry reviewer, Global GAMP SteerCo. 25+ years in pharma digital quality.
Leadership Orientation: AI & Digital Quality
- The strategic frame for leadership and decision-makers
- The four-tier risk model and who signs at each tier
- The questions to ask your teams before an inspector asks you
- The natural first step; teams graduate to the full programmes
Validating AI in GxP
- The full lifecycle on the TRUST framework, hands-on on one golden case
- Risk tiering, intended use, data lineage, evidence packs, drift and monitoring
- Positioned against draft Annex 22, FDA CSA, Part 11, Annex 11 and the EU AI Act
- Knowledge check and certificates of completion
Transitioning from CSV to CSA
- The four-step risk decision, practised on your own system inventory
- Right-sized evidence, and what "enough" looks like now
- Reviewer confidence: accepting rationale instead of screenshots
- Writing the transition into your Validation Master Plan
Prefer to talk it through first?
A 30-minute call with Sachin: bring your system list, leave with a clear read on which programme fits and what it should cover.
Request your training
A tailored proposal within one working day, and an invitation to a 30-minute call to shape the day.
What a session actually covers
Open a programme to read its agenda, or take the same thing away as a brief you can forward. No email required.
Leadership Orientation: AI & Digital Quality · the full agenda
2.5 hours · live online or onsite · up to 30 people in one sitting
| 0:00 | Welcome and objectives | Session goals and ground rules, and where this sits against the full practitioner programme. |
| 0:05 | Where AI validation now shows up commercially | How customer quality teams evaluate AI features during vendor selection, and the effect on review timelines and deal cycles. The mirror image for a manufacturer: what your own customers and inspectors will ask you. |
| 0:20 | The regulatory landscape, current and forthcoming | In force or final: EU Annex 11, 21 CFR Part 11, FDA CSA, the FDA and EMA joint AI principles, the EU AI Act. Forthcoming: the EU Annex 22 final, the Annex 11 revision, and the FDA AI credibility framework. Effective dates are mapped against your own timelines, because a purchase order is often the earliest point of enforcement. |
| 0:40 | The TRUST framework | The five-stage lifecycle worked end to end on a real case: tier the risk, bound the requirements and intended use, understand the data, substantiate with evidence, track in operation. The governance model that sits above it. |
| 1:10 | Break | Fifteen minutes. |
| 1:25 | Applied to your own systems | The assessment questions run against your AI features or platforms, with strengths and gaps read against Annex 22, FDA CSA and GAMP 5. See the note below on what this segment needs from you. |
| 1:55 | The maturity roadmap | The capability layers, from a documented intended use through to an evidence pack you could hand to a customer or an inspector, and how to sequence them. |
| 2:05 | Discussion and next steps | Open questions, and the inputs that shape a full training agenda if you take one. |
Validating AI in GxP · the full agenda
09:00 to 17:00 · 8 hours · onsite or live virtual · up to 30 people
| 09:00 | Why does my CSV instinct fail here? | The three breaks. What is new, and what is not. |
| 09:45 | May this system even exist? | Governance before validation. The operating model and who owns it. |
| 10:30 | What tier, and who signs? | The four-tier risk model. Delegates classify the case and defend it. |
| 11:30 | What am I claiming, and where does it stop? | Intended use statements and the human-in-the-loop boundary. |
| 12:15 | Where do Annex 22, CSA, Part 11 and the AI Act apply? | Positioning the rulebook, not reciting it. |
| 13:45 | Can I trust the data it learned from? | Representativeness, provenance, labelling, test data independence. |
| 14:45 | What evidence earns the validated state? | The validation plan, acceptance criteria, the three independences. |
| 15:45 | How do I keep it inside the envelope? | Monitoring, drift thresholds, retraining triggers, audit trail. |
| 16:30 | Am I inspection ready? | The evidence pack, the question bank, and each delegate's commitment. |
Transitioning from CSV to CSA · the full agenda
09:00 to 17:00 · 8 hours · onsite or live virtual · up to 30 people
| 09:00 | Why is our validation so heavy? | Where the documentation habit came from, and what guidance never asked for. |
| 09:45 | What did CSA actually change? | FDA CSA, GAMP 5 second edition and ICH Q9(R1) against Part 11 and Annex 11. |
| 10:45 | What is this system for? | Intended use and patient impact, written for your own system. |
| 11:30 | Which functions are high risk? | Risk that selects the assurance activity, worked in teams. |
| 13:30 | Scripted, unscripted or exploratory? | Choosing the method per function, and the record unscripted testing produces. |
| 14:45 | What can I rely on from the vendor? | Supplier assessment, and using vendor evidence without inheriting their gaps. |
| 15:45 | What evidence is enough? | Lean records, the screenshot question, and the rationale an approver can sign. |
| 16:30 | What are we stopping? | Each delegate names one practice to retire, and what replaces it. |
Booking, answered
What does a session cost?
The Leadership Orientation is from ₹1,50,000. Transitioning from CSV to CSA is from ₹3,50,000. Validating AI in GxP is ₹5,00,000, which the LAUNCH25 code brings to ₹3,75,000 until 15 September 2026. Every figure is India pricing, per session for a batch of up to 30 participants, plus GST, with travel on actuals. No per-seat pricing. International delivery is priced on request.International sessions are quoted per country, per session for a batch of up to 30 participants, with no per-seat pricing. Send the form and you will have a country-specific quotation within one working day, including the launch offer where it applies.
Is the training generic or built on our systems?
Built on yours. Sessions work on your system inventory, your SOPs and your inspection history, and teams leave with output they can use the next working day. The flagship closes with a knowledge check and certificates.
How fast can a date be confirmed?
You receive a tailored proposal within one working day of the form. Dates are held on a released purchase order or advance, and most sessions deliver within four to six weeks of booking.