AI Governance &
Validation in GxP:
What Regulators
Actually Expect
A 2-hour global expert session on deploying AI in clinical and quality workflows safely, compliantly, and with full audit-trail confidence — from validation frameworks to practical oversight strategies.
Complimentary · Recording available to all registered participants
GxP AI Expert · Barcelona
GxP AI Governance & CSV Expert · California
AI is already in your QA workflow.
Is your governance ready?
FDA, EMA, ICH E6(R3), EU AI Act, and ISO 42001 are actively addressing AI in regulated environments. This webinar bridges the gap between what regulators expect and what practitioners actually face.
Regulatory Landscape
ICH E6(R3), EU AI Act, FDA AI/ML guidance, GAMP 5, Annex 11, and ISO 42001 — know what AI compliance looks like in 2026 across every major regulatory jurisdiction.
CSA / CSV for AI Systems
AI tools are not Category 1. Learn how Computer Software Assurance (CSA) and Computerized System Validation (CSV) apply to LLMs, AI-assisted audits, and SaMD — with 21 CFR Part 11 and Annex 11 obligations.
Practical Oversight Design
How to design proportionate human oversight into AI-assisted processes so every AI output is auditable, traceable, and defensible in an FDA, EMA, or ISO 13485 inspection.
Full 2-Hour Agenda
Structured presentation blocks followed by a 60-minute live dialogue with Chandra — the format that creates real exchange, not just slides.
1Presentation Blocks (60 min)
- ICH E6(R3) §5 and the technology-neutral clause
- EU AI Act risk classification for pharma & biotech use cases
- FDA AI/ML action plan: where clinical QA fits
- ISO 42001 vs NIST AI RMF — which framework fits GxP?
- What "AI oversight" means in an inspection context
- GAMP 5 2nd edition: where does AI fit in the software category system?
- 21 CFR Part 11 & Annex 11: audit trail obligations for AI outputs
- CSA vs CSV for AI tools: intended use, risk assessment, URS
- Data integrity controls: ALCOA++ applied to AI-generated findings
- SaMD and AI/ML: FDA Software as a Medical Device guidance
- QARP AI Workspace: document analysis & finding generation
- What inspection-ready AI output looks like (citation trail)
- Validated AI audit assistant vs. unvalidated chatbot: the difference
2Live Dialogue with Chandra (60 min)
- How sponsors, CROs, and biotech companies are implementing AI governance today
- The biggest misconceptions about AI validation in clinical & GMP environments
- Risk-based AI oversight: what's proportionate across GMP, GCP, GLP, GDP?
- Building an AI governance SOP that survives an FDA or EMA inspection
- Data residency, confidentiality & GDPR when using AI in regulated workflows
- AI in audit reports & submissions: what are inspectors asking?
- Live Q&A from global participants
- Practical AI governance readiness checklist
- Recommended resources, frameworks & next steps
What Chandra & Maxim Will Cover
60 minutes of structured exchange between two practitioners — drawing on 30+ combined years of GxP audits, CSV implementations, and AI deployments in regulated environments.
Two Practitioners, One Conversation
Both speakers bring active field experience across GMP, GCP, GLP, GDP — not theoretical frameworks alone.
Independent GxP auditor with 500+ audits across EU, CIS, and MENA. Founder of The QARP AI Workspace — a GxP-native AI audit assistant built on ICH E6(R3) methodology. Pioneer of AI-assisted audit finding generation, CAPA drafting, and RBQM review in clinical quality assurance. Trainer and curriculum developer for GCP Auditor School, delivering advanced GxP education to 1,000+ professionals globally.
30+ years driving quality assurance and compliance across biopharmaceutical, biotech, cell/gene therapy, and medical device industries. Expert in Computer Software Assurance (CSA), Computerized System Validation (CSV), and AI adoption in Life Sciences. Recognized for building phase-appropriate QMS programs, inspection readiness for FDA/EMA/MHRA, and comprehensive internal/vendor audit management. MSc from Indian Institute of Science (IISc). CMQ/OE certified · ISO 13485/9001 Lead Auditor.
Practical Competencies, Not Just Concepts
Every participant leaves with immediately actionable knowledge for their organisation.
Regulatory Map
A clear map of all AI-relevant regulatory expectations in 2026: ICH E6(R3), EU AI Act, FDA, GAMP 5, ISO 42001, NIST AI RMF, Annex 11.
CSA/CSV Checklist
A practical validation checklist for AI tools in GxP workflows — what documents you need, what tests are required, how to handle 21 CFR Part 11.
Oversight Framework
A model for designing proportionate human oversight into AI-assisted audit, QMS, and clinical processes that satisfies regulators.
SOP Key Elements
The critical components every AI governance SOP must contain to survive an inspection — and how to integrate it into your existing QMS.
Inspection Answers
How to respond when an FDA, EMA, or ISO 13485 inspector asks "how is your AI tool validated?" — with confidence and specificity.
Recording & Materials
Full recording + speaker slides + AI governance readiness checklist sent to all registered participants within 48 hours of the live session.
Built for the GxP Professional Using — or Evaluating — AI
If your work touches clinical quality, compliance, or audit in any capacity, this session is directly relevant to your regulatory reality.
QA Managers & GxP Auditors
CSV / CSA & System Validation Specialists
Regulatory Affairs Professionals
Clinical Operations & CRO Leaders
Sponsor QA Directors & VP Quality
Cell & Gene Therapy Quality Teams
GMP, GLP & GDP Quality Professionals
Medical Device & SaMD QA Specialists
Join Us on
19 June 2026
This is a complimentary educational webinar — no sales pitch, no upsell. Two expert practitioners sharing what they know from 60 combined years in GxP quality and compliance.
What's Included
- 2 hours of live expert content & structured dialogue
- 60-minute expert exchange with live Q&A
- Full recording delivered within 48 hours
- Speaker slides & curated resource list
- AI governance readiness checklist
- Certificate of participation (upon request)
You're registered!
Check your inbox — we'll send your Zoom link and a calendar invite within a few hours. A reminder follows 24 h and 1 h before the session.
Prefer email? Write to info@theqarp.com
Common Questions
Is this webinar really free?
Yes — completely free. No payment, no credit card. Simply register and a Zoom link will be sent to you. This is an educational initiative by The QARP.
What language will the webinar be in?
The entire session will be conducted in English. Slides and materials will be in English.
Will there be a recording?
Yes. A full recording will be sent to all registered participants within 48 hours of the live session, regardless of whether you attended live.
What platform will be used?
Zoom. Login credentials will be sent to your registered email 24 hours before the session and again 1 hour before start.
Can I submit questions in advance?
Yes — after registering you will receive a form to submit questions for the live dialogue. Questions may be answered live or included in the post-event resource pack.
Is a certificate of participation available?
Yes. Participants who attend the live session can request a certificate for 2 CPD hours by emailing info@theqarp.com after the event.