GxP AI Validation: From Regulatory Expectations to a Defensible Validated State
AI is already part of batch release, clinical operations, pharmacovigilance and quality systems, and the rules for it are already in force. This course shows you how to validate AI in a regulated environment in a way that holds up in an inspection.
The rules for AI in GxP are already here
All of these apply to systems you may be running today. Traditional CSV is still necessary, but it is no longer enough.
What you will learn
A practical framework you can apply to the AI systems in your own organisation.
- How eight regulatory frameworks fit together, and which one sets each specific obligation
- Why probabilistic AI needs different controls than deterministic software, and how a five-layer governance model connects the two
- How to tell generative, adaptive and agentic AI apart, and size validation effort to the real risk
- The Five Pillars of AI Validation: Operational Boundaries, Accountability Trail, Drift Detection, Behavioural Baselines and Escalation Testing
- How to choose the right human oversight model (HITL, HOTL or HIC) and set escalation thresholds your team can actually handle
- A Regulatory Mapping Matrix that links every control to FDA, EU, ISO and NIST requirements, so you have an answer when an auditor asks “why”
- Where your responsibility starts with embedded vendor AI versus custom-built models, including multi-agent systems
- A risk-based IQ / OQ / PQ / Periodic Performance Review lifecycle for AI
- The six core AI validation documents you need, plus the roles your organisation will have to create
Learn from real cases
You will work through a custom-built AI agent for QA batch record review and an embedded AI module in a vendor CTMS. The CTMS case covers a “pre-validated” claim that wasn't enough, drift that the vendor never flagged, and an escalation threshold that overwhelmed the clinical operations team. Four more industry examples follow.
Leave with a plan
The course finishes with an 18-month implementation roadmap, an introduction to MLOps and continuous assurance, and a capstone exercise: a mini-validation brief for an AI system from your own organisation.
Programme: 17 modules
Each module has lessons in video and text, a practical exercise and a quiz.
- 01The Regulatory & Standards Landscape
- 02Why AI Validation Is Different from Traditional CSV
- 03The Five-Layer Governance Architecture
- 04Three Categories of AI in Regulated Life Sciences
- 05The Five Pillars of AI Validation
- 06Global Standards Deep-Dive (FDA, EU, ISO, NIST)
- 07Regulatory Mapping Matrix
- 08Embedded vs. Custom-Built AI Systems
- 09Multi-Agent Validation Complexity
- 10Validation Testing Approach: IQ / OQ / PQ / PPR
- 11Key Validation Documents
- 12AI Literacy, Roles & Knowledge Management
- 13Case Study 1: Batch Release AI Agent
- 14Case Study 2: Embedded AI in CTMS
- 15Additional Industry Case Studies
- 16Implementation Roadmap
- 17Key Takeaways & Next Steps
Who this course is for
QA and validation professionals, CSV and computerised-system specialists, GxP auditors, IT and data-science teams in regulated companies, and regulatory affairs staff who need to bring AI under control. You need a basic understanding of GxP and CSV.
Built and delivered by The QARP
An international network of independent GCP and GxP auditors, QA consultants and trainers.
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Pay securely by card through Stripe. Your access opens on The QARP Academy right after payment.
- 17 modules, 62 video and text lessons
- Practical exercises and a quiz for every module
- Real case studies and an 18-month roadmap
- Certificate of completion
- Self-paced, on The QARP Academy platform
Frequently asked questions
How do I get access after payment?
Right after payment we create your account on The QARP Academy (theqarpacademy.pro), open the course for you and send your login details to the email you entered. If you already have an Academy account with that email, the course appears in it.
Do I get a certificate?
Yes. When you complete the course, The QARP Academy issues your certificate of completion, and you can download it as a PDF.
What do I need to know before I start?
A basic understanding of GxP and CSV. The course is in English and fully online, so you can study at your own pace.
Can my company pay by invoice?
Yes. Request an invoice on the course page on The QARP Academy and we will send it to you.