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Winter 2027 · Waitlist

Validate AI in regulated industries.
Build the credential that proves it.

A 9-week practitioner program for quality, validation and regulatory professionals. Live sessions, real cases, a recognised credential.

Join the waitlistExplore the program
9 weeks · live + async24 seats per cohort47 real-world casesGAGP credential included

9-week program

Five modules. Real deliverables. One credential.

MODULE 01Weeks 1 – 2 · 8 h

AI Systems in Regulated Environments

Context, risk classification, GAMP 5 applied to AI and ML systems.

Deliverable: Risk classification memo
MODULE 02Weeks 3 – 4 · 8 h

Validation Strategy and Planning

Designing a fit-for-purpose validation plan for AI/ML systems.

Deliverable: Validation plan outline
MODULE 03Weeks 5 – 6 · 9 h

CSV for AI/ML Systems

Computer system validation adapted for continuous-learning models.

Deliverable: Protocol draft
MODULE 04Weeks 7 – 8 · 9 h

Audit Readiness and Lifecycle Management

Preparing for FDA 483s, notified body audits and change control.

Deliverable: Audit-readiness checklist
MODULE 05Week 9 · 6 h

Capstone — Real-World AI Validation

Present your validated AI scenario to a three-person panel.

Deliverable: Capstone defense

Pricing

Join as an individual or bring your team.

Winter 2027 · Waitlist open

Individual

1 seat

Full 9-week program, credential exam, case library, community.

$2,400$3,200

Early-bird rate

Apply

Team of 4

4 seats

Four seats, private workspace, shared capstone on your own scenario.

$8,400

$2,100 per seat

Apply

Enterprise

3 or more teams, private cohort, custom case library, executive briefing.

Custom pricing

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