GxP Vigilance Training · Level 2
Carl introduced NotebookLM at the ARCS Australia PV Symposium. The room got it immediately. This 90-minute Level 2 session is the follow-on — hands-on, GxP-appropriate, and built around the workflows that pharmacovigilance, regulatory affairs, and pharmacy professionals actually run.
90
Minutes Focused
6
Practical Modules
4
Professional Roles
$30
AUD Per Person
Session Content
You won't sit through slides. Every module is built for immediate application — techniques you can use on Monday in the workflows you run every day.
Module 01
Quick recap of the Level 1 concepts. Confirm your workspace is configured correctly for GxP-appropriate use before we move forward.
Module 02
Load TGA guidance, GVP modules, and SOPs into notebooks with purpose. Learn what to upload, what to exclude, and why those boundaries matter for data integrity.
Module 03
Prompting techniques that surface accurate, cited answers from your regulatory corpus — with traceability you can defend at inspection.
Module 04
Practical application across adverse event case review, signal documentation, and literature summaries. Where AI assists — and where your accountability is non-negotiable.
Module 05
What NotebookLM records and what it doesn't. How to maintain an auditable human decision layer when AI is part of your PV workflow.
Module 06
Bring your actual use cases. Live troubleshooting and boundary-setting for your specific role, organisation type, and regulatory context.
Who Should Attend
Pharmacovigilance Managers & Associates
ICSR processing, signal management, aggregate reporting, literature review.
Regulatory Affairs Professionals
TGA submissions, correspondence, guidance navigation and search.
Pharmacy Practitioners
Medicines information, clinical decision support, regulatory guidance look-up.
Quality & Compliance Staff
SOP review, CAPA documentation, audit preparation with human-in-the-loop AI.
What You Get
Your Presenter
Every technique in this session has been applied to real regulatory work. This is capability transfer — not a vendor briefing, not a demo. Carl uses these tools daily in active PV and GxP practice.
Carl Bufe
The AI-Native GxP Practitioner · Director, GxP Vigilance
Registered Pharmacist, QPPV, and ISO 9001 Lead Auditor with 24 years of pharmaceutical operations experience. Carl combines active clinical practice with AI governance consulting and regulatory auditing across Australia and APAC. He was a featured presenter at the 2026 ARCS Australia Pharmacovigilance Symposium — this Level 2 session is the direct follow-on to that session.
Register Now
Secure online registration · Invoice available on request


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