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Chandramohan ThiruvamkulamStrategic Quality Executive
GxP AI Governance & CSV Expert · California30+ 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 - Maxim BunimovichCEO & Founder, The QARP
GxP AI Expert · BarcelonaIndependent 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.
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
EU AI Act, FDA AI principles, ICH E6(R3), 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 validation apply to LLMs, AI agents, and AI-assisted audits — 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.
AI Governance in GxP Practice — Full 2-Hour Agenda
A governance-first programme built around a live, end-to-end demo of QARP AI. Theory lands through what the tool actually does — every concept is shown, not just described. 19 June 2026 · 16:00–18:00 CEST.
- Why now — the state of AI in regulated quality work in 2026
- The FDA "Elsa" moment: what it tells us about AI governance inside the regulator — and in industry
- What AI governance actually means operationally in GxP — not policy, but controls
- Intended use, scope boundaries, accountability split: QA / IT / Legal
- Regulatory landscape 2026: EU AI Act, FDA AI principles, ICH E6(R3), ISO 42001
- Poll: where is your organisation on the governance maturity curve?
- How do you validate something probabilistic by design?
- CSA risk-based approach applied to LLMs and AI agents
- What validation evidence looks like for generative AI
- Audit trail: what must be logged, by whom, in what format
- Reproducibility problem: same prompt, different output — how to manage
- Confidentiality & data residency: what goes in, what must not
- Where human checkpoints are mandatory vs. advisory
- FDA April 2026 warning letter: "any AI output must be reviewed and cleared"
- Hallucinations as a managed risk — not a reason to avoid AI, but to govern it
- CAPA logic: when AI causes a deviation, who owns it
- Document upload & anonymisation (up to 10 docs)
- AI-assisted audit preparation: programme, checklist, red flags
- Live finding generation during the conduct phase
- Report drafting — section by section, with human review at each step
- Showing: audit trail, human-in-the-loop checkpoints, confidentiality controls
- How to build the governance paper trail around an AI-assisted process
- SOP and work instruction design for AI tools
- Inspection readiness: what an auditor or FDA reviewer will look for
- Open floor — QA, IT and Legal perspectives all welcome
- Key takeaways
- Access to QARP AI Governance resources & the founding user programme
Total: 120 min · The demo is the centrepiece — governance theory lands through what the tool actually does. Can't attend live? The full session will be available on demand on the QARP platform.
What Chandra & Maxim Will Cover
Structured exchange between two practitioners — drawing on 30+ combined years of GxP audits, CSV implementations, and AI deployments in regulated environments.
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: EU AI Act, FDA AI principles, ICH E6(R3), GAMP 5, ISO 42001, 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.
On-Demand Access
Full recording available on demand on the QARP platform, plus speaker slides and the AI governance readiness checklist — sent to all registered participants within 48 hours.
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
IT, Legal & Compliance Stakeholders
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. The full session will be available on demand on the QARP platform, and a recording is sent to all registered participants within 48 hours — whether or not you attended live.
What platform will be used?
Zoom for the live session. 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 Q&A. 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.