GxP Vigilance Training · Google AI Tools for Regulatory Practice
You've Seen the Introduction.
Now Build a Practice That Actually Uses It.
NotebookLM, Gemini, and Google Workspace AI — three tools, one practical workshop. Built for regulatory affairs, pharmacovigilance, and pharmacy professionals ready to move from awareness to application.
90+60
Min · Core + Bonus
8
Modules inc. Bonus
50
Capacity per Session
30
Bonus Seats (07–08)
$97
AUD Per Person
Delivered as a private pilot session with 10 industry client professionals on 5 May 2026. Content was refined directly from their feedback before public release.
Platform Updates · Late 2025 – 2026
The Google AI Stack Is Moving Fast. So Should Your Practice.
Gemini, NotebookLM, and Google Workspace have shipped major updates almost every month since late 2025. New artifact types, deeper integrations, and persistent state are changing how regulatory teams use these tools day to day. This workshop is built on the current platform — not last year's screenshots.
- Apr 2026Gemini for Mac — native desktop app with Option+Space shortcut, screen-context sharing across any application.
- Feb 2026Gemini 3.1 Pro released for complex problem-solving; Gemini 3 Deep Think upgraded for science, research, and engineering.
- Jan 2026Gemini in Chrome rebuilt on Gemini 3 — side panel, Workspace integration, auto-browse preview for Pro/Ultra subscribers.
- Jan 2026Personal Intelligence — Gemini can now draw on Gmail, Photos, YouTube, and Search history with explicit opt-in.
- Dec 2025Gemini 3 Flash is now the default model; new experimental Gems from Labs (custom AI mini-apps).
- Nov 2025Gemini Agent — multi-step task agent with confirmation gates before sending email or making purchases.
- Apr 2026Auto-categorise sources when a notebook crosses 5+; bulk share; persistent flashcard progress across sessions.
- Mar 2026Cinematic Video Overviews (Veo 3-powered); EPUB as a source type; saved conversation history across sessions; in-chat artifact creation.
- Mar 2026Slide revisions — request stylistic or factual changes per slide; ten new infographic styles.
- Feb 2026Prompt-based slide editing ("fix slide 3") and PPTX export alongside PDF.
- Jan 2026NotebookLM as a source inside Gemini — attach notebooks to custom Gems so they auto-sync as you add sources.
- Dec 2025Data Tables — synthesise multiple sources into structured tables with export to Google Sheets.
- Apr 2025NotebookLM & Gemini app as Workspace Core Services with enterprise-grade data protection — rolled out to Education customers and progressively extended through 2025–2026.
- 2025–26NotebookLM Enterprise on Google Cloud — VPC-SC compliance, IAM controls, and audit trails for regulated environments.
- Jul 2025Productivity Planner Gem connects Gmail, Calendar, and Drive for Business and Education plan users — premade Gem updated through 2025–2026.
- Feb 2026Flow (Google Labs) — refined controls for video generation and content refinement workflows.
- Sep 2025Shareable Gems — Gems can now be shared like Drive files, with view or edit permissions for teams and organisations.
- Oct 2024Gemini app SOC 2 / SOC 3 compliant for Workspace customers (AICPA-audited), with no training on customer data.
For regulatory practitioners, the pace itself is the issue. New artifact types and integration points create new validation, governance, and audit-trail questions. Course materials are reviewed continuously, with literature monitored weekly to ensure content reflects the platform as it stands at the date of delivery — and Module 06 holds open time specifically for the questions you bring on the day.
Workshop Content
Eight Modules. NotebookLM, Gemini, and Google Workspace — All in One Session.
Modules 01–06 run for 90 minutes — a hands-on working session built entirely around regulatory workflows. The first 30 registrants stay on for Bonus Modules 07 & 08, an additional 60 minutes of live applied training. Every technique is grounded in TGA, GVP, and ICH obligations.
Module 01
NotebookLM Refresher & Workspace Setup
A focused recap for ARCS Summit attendees and structured onboarding for those new to the session. Confirm your notebook is configured correctly before the applied work begins.
Module 02
Organising Regulatory Source Documents
Load TGA guidance, GVP modules, ICH annexes, and SOPs into notebooks with purpose. Document boundary decisions, upload governance, and data integrity principles for GxP contexts.
Module 03
Querying with Regulatory Precision
Prompting techniques that surface accurate, cited answers from your regulatory corpus — with the traceability you need to defend outputs at audit or inspection.
Module 04
Using NotebookLM to Build Training Materials
Turn your regulatory corpus into structured training resources — scenario-based exercises, briefing documents, and competency-check content — with full traceability back to source guidance.
Module 05
Introducing Gemini & Gems for Regulatory Work
From NotebookLM to Gemini — where each tool fits in your workflow. Building custom Gems scoped specifically for PV, regulatory affairs, and quality tasks.
Module 06
Open Q&A — Your Questions, Your Workflows
Dedicated time for your specific questions. Bring your use cases, your challenges, and your regulatory context. Live answers on boundaries, governance, and practical application.
Bonus Module 07 · 30 min
Maximising Gemini — Advanced Deep-Dive
Goes beyond the Module 05 introduction into advanced Gemini configurations, multi-step prompting sequences, and Gems built for pharmacovigilance and regulatory submission support. Where we push the capability — with governance guardrails throughout.
Bonus Module 08 · 30 min
Gemini in Google Workspace — Writing SOPs
Practical application of Gemini in Google Docs and Drive for regulatory document creation. Drafting and refining Standard Operating Procedures, regulatory correspondence, and structured GxP documents — with governance controls appropriate for inspection environments.
Learning Outcomes
What You Will Be Able to Do on the Next Working Day.
Outcomes are competency-based and pharma-specific. Each one ties directly to a module in the workshop and to the kind of task a regulatory affairs, pharmacovigilance, or quality professional performs in active practice.
Configure a NotebookLM environment appropriate for regulatory work — including source organisation, boundary decisions, and upload governance for TGA, GVP, and ICH material.
Apply prompt patterns that maintain source traceability and produce citation-backed outputs defensible at audit, inspection, or internal review.
Distinguish between use cases appropriate for unvalidated AI knowledge work and those requiring additional qualification, validation, or quality controls under GxP.
Design custom Gems scoped for specific regulatory tasks — pharmacovigilance support, dossier preparation, guidance interpretation — with governance guardrails defined.
Generate training, briefing, and competency-check materials from a regulatory source corpus with full traceability back to original guidance documents.
Evaluate NotebookLM Studio output types (Audio Overviews, Video Overviews, Mind Maps, Data Tables, Reports) against the artifact requirements of regulatory practice.
Identify the governance, data-handling, and audit-trail considerations that apply when using Google AI tools alongside — but outside — regulated processes.
Translate ARCS Summit awareness into a personal, repeatable workflow you can apply to active casework the next working day.
A certificate of attendance is provided to all participants. The workshop is equivalent to approximately 2.5 hours of professional development activity for the first 30 registrants per session and 1.5 hours for participants 31–50 (live core only, with recorded access to bonus modules). Outcomes are aligned to the modules listed above and can be mapped to internal training records on request.
Who Should Attend
For Regulatory Practitioners Ready to Move from Awareness to Application.
This workshop is for people with a regulatory obligation — not teams exploring AI in general. No technical background required. If you attended the ARCS Summit session, this is the next step.
Regulatory Affairs Managers & Associates
TGA submissions, guidance navigation, correspondence, dossier management, SOP development.
Pharmacovigilance Professionals
ICSR support, signal documentation, aggregate report preparation, GVP compliance.
Quality & Compliance Staff
SOP drafting, CAPA documentation, training material development, audit preparation.
Pharmacy Practitioners
Regulatory correspondence, medicines information, clinical governance documentation.
What You Get
A Full Workshop Built Around Regulatory Work — for $97.
Workshop Scope & AI Governance
This workshop addresses the individual knowledge-work use of Google AI tools by regulatory professionals — not their use within validated GxP systems. Validation of AI for use inside regulated processes requires separate qualification, validation, and quality controls under GxP requirements, and is not in scope here.
Your Presenter
Practitioner-Led. ARCS-Recognised. Built on Active Regulatory Practice.
Carl uses these tools in live regulatory and PV work. He has presented at ARCS and will chair the AI session at the ARCS Annual Conference — this workshop reflects exactly the practical, governance-first approach he brings to every engagement.
Carl Bufe
The AI-Native GxP Practitioner · Director, GxP Vigilance · ARCS Conference AI Session Chair
Registered Pharmacist, QPPV, and ISO 9001 Lead Auditor with 24 years of pharmaceutical operations experience. Carl presented on Google AI tools for regulatory professionals at the 2026 ARCS Regulatory Summit and will chair the AI in Regulatory Affairs session at the ARCS Annual Conference. He integrates NotebookLM, Gemini, and Google Workspace AI into active GxP practice — including pharmacovigilance operations, TGA-facing regulatory work, and quality systems. Director of GxP Vigilance (BioSyn-AI Pty Ltd) and lead trainer at pharmaaitrainingonline.com.
Register Now
Two Dates. 8 Modules. One Practical Workshop. $97.
Secure online registration · Invoice available on request
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