Microlearning Series · 15 Lessons · Delivered on Reach 360 · Certificate of Completion
AI Is Moving Faster Than Your Compliance Program.
Most organizations are investing in AI. Very few are preparing their workforce to govern it.
This program changes that. Learn how CSA, AI Governance, validation, and regulatory expectations intersect — and earn the certification that proves you’re ready.
15
Focused Lessons
Two tracks: CSA Foundations (10) + AI Governance & Validation (5)
~5 min
Per Lesson
Practical insight in minutes — not hours. Built for busy life sciences teams.
1
Of Its Kind
The only CSA & AI Governance Certification built exclusively for Life Sciences compliance.
Reach 360
Platform
Interactive graphics, decision trees, and real-world case studies — built to apply immediately.
The Governance Gap
Organizations are deploying AI faster than they are preparing people to govern it.
Teams are launching AI tools across quality, manufacturing, clinical, and business processes — but most have never been trained on how AI changes compliance responsibilities, how CSA principles apply to AI-enabled systems, or what governance frameworks like ISO/IEC 42001 actually require. The result is inconsistent decisions, increased audit risk, and exposure that builds quietly until the FDA asks.
The Problem
Traditional Compliance Training Wasn’t Built for AI.
Most compliance training programs were created before Generative AI, Agentic AI, AI-assisted decision making, ISO/IEC 42001, and modern CSA approaches existed. This program was built for where the industry is today.
Microlearning
Practical insight delivered in minutes — not hours. Built for busy life sciences teams who can’t disappear into a week-long training course.
Risk-Based
Scale effort to patient risk, product quality, and intended use — and cut needless burden. CSA as a methodology change, not a checkbox.
Inspection-Ready
Generate defensible, audit-ready assurance that holds up to regulatory scrutiny. Every lesson connects directly to what inspectors actually ask.
AI-Ready
Govern AI for Annex 22, the EU AI Act, and the emerging regulatory landscape. Practical frameworks you can take back and put to work immediately.
Full Curriculum
15 lessons. Two tracks. One certification.
Across 15 focused lessons, teams gain strategies they can apply immediately — from risk-based assurance and modern testing to AI governance and a practical, defensible AI validation framework. Each lesson is built in Reach 360 with interactive graphics, real-world examples, and a completion certificate.
Track 1 · Lessons 01–10
CSA Foundations
Introduction to CSA and Why It Matters
Where traditional CSV fell short — and how CSA redirects effort toward the features that truly protect patient safety, product quality, and data integrity.
Risk-Based Approach in CSA
How risk becomes the anchor of every CSA activity — scaling assurance to real-world impact instead of testing everything exhaustively.
Infrastructure and Vendor Qualification
How deployment models and risk-based vendor qualification shape a CSA strategy, and how to leverage supplier evidence instead of duplicating effort.
Applying Critical Thinking in CSA
Critical thinking replaces prescriptive checklists with scientific judgment built on three questions: what could go wrong, what’s the impact, how do we mitigate it.
Requirements and Intended Use Best Practices
Intended use is the foundation of validation. Learn to write clear, testable, risk-based requirements that anchor assurance to what a system is actually meant to do.
CSA for GxP and Non-GxP Systems
CSA scales across the whole estate — rigorous practices for GxP systems and a lighter, fit-for-purpose approach for non-GxP platforms.
Functional Testing, Evidence & Unscripted Testing
Modern testing matches method to risk. Scripted and unscripted approaches working together, with objective evidence that is clear, risk-based, and outcome-driven.
Functional Testing, Evidence & Unscripted Testing
Modern testing matches method to risk. Scripted and unscripted approaches working together, with objective evidence that is clear, risk-based, and outcome-driven.
Agile Validation Within CSA
CSA and Agile are natural partners — both iterative, risk-driven, and focused on working systems over paperwork.
Change Management and Auditing Under CSA
Proportionate change control and audit readiness keep systems in a validated, defensible state as they evolve after go-live.
The Future of CSA — Digitization & AI
Where validation is heading: digital validation tools, Validation 4.0, and continuous, data-driven assurance that extends CSA principles into AI and machine learning.
Track 2 · Lessons 11–15
AI Governance & Validation
Understanding AI in GxP: What Makes It Different
AI isn’t just more sophisticated software — it’s probabilistic, it fails differently, and it needs a different compliance approach. Understand why the legacy playbook doesn’t transfer.
AI Governance Frameworks & the Regulatory Landscape
Annex 22 is published and the EU AI Act is in force. Map the converging frameworks and the operating model that turns AI governance into a strategic capability.
Scoping AI Under CSA: The Decision Influence Test
AI becomes GxP by impact, not by design. Use the Decision Influence Test to scope AI correctly — avoiding over-classification and dangerous under-governance.
Responsible AI: Data Governance & Accountability
Treat training data as a regulated asset, read data silence as a risk signal, and distribute accountability across People, Process, and Technology.
Capstone: A Practical AI Validation Approach — A–B–C–D–E
A repeatable, defensible methodology illustrated through a real GenAI case study that produces the evidence regulators now expect.
The A–B–C–D–E Framework
The capstone: a repeatable AI validation methodology.
Lesson 15 covers the A–B–C–D–E framework — a structured, step-by-step process illustrated through a real GenAI case study that produces the evidence regulators now expect.
A
Assess
Define intended use and classify each Context of Use by process risk.
B
Benchmark
Generate statistically defensible performance evidence (Cochran method).
C
Control
Apply configuration management and controlled change throughout.
D
Data & Governance
Govern training data, lineage, and oversight as regulated assets.
E
Ensure
Sustain assurance with continuous, lifecycle-long monitoring.
Who It’s For
AI will not replace compliance professionals. AI-literate compliance professionals will.
The organizations that succeed with AI will not be those with the most technology. They will be the organizations with the best-prepared workforce to govern it. The ability to evaluate AI risks, validate AI-enabled systems, and establish effective governance controls is quickly becoming a core competency.
Quality & Compliance
QA Directors, VP Quality & Quality Managers
Understand what AI governance requires from a quality systems perspective — and how to build a program that satisfies inspection expectations.
Validation
Validation Engineers & Specialists
Apply CSA methodology correctly to AI systems — risk-based validation approaches, testing strategy, and audit-defensible documentation.
Regulatory Affairs
VP Regulatory & Regulatory Associates
Navigate FDA’s evolving AI guidance, EU AI Act obligations, and ISO/IEC 42001 requirements with practical implementation frameworks.
IT & Digital Leaders
IT Directors & Digital Transformation Leads
Build the technical infrastructure that makes AI governance operational — with compliance built in from the start.
Compliance Teams
Anyone Responsible for Compliance Programs
Establish a common framework so every team has the same interpretation of “responsible AI” — not each department figuring it out independently.
Digital Transformation
Leaders Driving Modernization
Ensure AI adoption programs are governed, validated, and defensible — before the FDA asks for it.
Why Compliance Group
Learn from the team helping shape the future of compliance.
Compliance Group has helped Life Sciences organizations modernize quality and validation programs through CSA, digital transformation, and AI initiatives. This certification combines those disciplines into a practical learning experience designed specifically for regulated industries.
ISO/IEC 42001 — Only certified AI Management System in life sciences compliance FICSA Co-founders of the FDA Computer Software Assurance guidance team 25+ years of GxP expertise behind every lesson GAMP 5 Second Edition co-authors 300+ GxP system knowledgebase 60+ regulated client organizationsCertification
Upon successful completion, participants earn a Certified in CSA & AI Governance credential issued by Compliance Group — demonstrating foundational knowledge of CSA principles, AI Governance, AI risk management, AI validation concepts, and responsible AI deployment in regulated environments.
The certification program is the foundation. CLAiRE AI Agents automate the compliance activities your team now knows how to govern. iQuality embeds AI governance natively across DX, VX, and QX. MAiGRATE makes legacy data migration audit-defensible. All operate under our ISO/IEC 42001-certified AI Management System.
AI Adoption Is Accelerating
Governance Skills Must Keep Pace.
Give your team the knowledge and framework needed to deploy AI responsibly, confidently, and compliantly. Request a sample lesson or speak with an expert today.