The program
Nine weeks. Real work. One credential.
Nine-week timeline
Week 1
AI in regulated industries
Context and stakes
Week 2
Risk and classification
GAMP 5 applied to AI
▸ Deliverable due
Week 3
Validation frameworks
Choosing your approach
Week 4
Writing the validation plan
Hands on
▸ Deliverable due
Week 5
CSV protocols for AI
IQ, OQ, PQ adapted
Week 6
Testing and evidence
What regulators want
▸ Deliverable due
Week 7
Audit readiness
Mock audit workshop
Week 8
Lifecycle and change control
Post-validation
▸ Deliverable due
Week 9
Capstone defense
Panel presentation
▸ Defense
Five modules
AI Systems in Regulated Environments
Context, risk classification, and GAMP 5 applied to AI and ML.
Validation Strategy and Planning
Designing a fit-for-purpose validation plan for AI/ML systems.
CSV for AI/ML Systems
Computer system validation adapted for continuous-learning models.
Audit Readiness and Lifecycle Management
Preparing for FDA 483s, notified body audits and post-market change control.
Capstone — Real-World AI Validation
Present your validated AI scenario to a three-person expert panel.
Format — 40 total hours
Capstone rubric
Five criteria, scored 1 to 5 by a three-person panel. Pass threshold: 18 of 25.
Risk identification and GAMP 5 categorisation
Validation strategy and scoping
Protocol quality and traceability
Evidence completeness and integrity
Regulatory readiness and defensibility
Faculty
Rosalind Beasley
Founder · Faculty Director
Co-founder of Genari AI. Multi-decade career in life sciences quality and regulated technology.
What I teach: Foundations of AI in GxP · Leadership & Governance · capstone defense
Tim Kirkelie
Co-Founder · Product
Co-founder of Genari AI. Lead architect of the GxP Genie AI-native validation product.
What I teach: Risk Framework · Architecture & Security · capstone build clinics