Curriculum

13 competency tracks. Role-based assignment.

You train what your team actually needs. Every track maps to a published FDA, EMA, ICH or EU AI Act expectation.

GxP Frame — Curriculum Walkthrough

The full catalogue

Foundational

Tracks 1–2

Operational Guardrails

Tracks 3–6

Applied Skill-Building

Tracks 7–9

Compliance Infrastructure

Tracks 10–12

Capstone

Track 13

Every track maps to a published expectation

Select a framework to see which tracks carry it. The crosswalk is the same one used in the curriculum’s regulatory alignment matrix.

Curriculum tracks mapped against FDA, EMA, ICH and EU AI Act expectations.
Track
AI Fundamentals AI Fundamentals maps to FDA Draft AI Guidance — AI Fundamentals maps to FDA–EMA Good AI Practice Principles AI Fundamentals maps to EMA Reflection Paper AI Fundamentals maps to ICH M15 (Model-Informed Drug Development) AI Fundamentals maps to EU AI Act (Adjacent)
AI Governance & Regulatory Expectations AI Governance & Regulatory Expectations maps to FDA Draft AI Guidance AI Governance & Regulatory Expectations maps to FDA AI-Enabled Devices Guidance AI Governance & Regulatory Expectations maps to FDA–EMA Good AI Practice Principles AI Governance & Regulatory Expectations maps to EMA Reflection Paper AI Governance & Regulatory Expectations maps to ICH M15 (Model-Informed Drug Development) AI Governance & Regulatory Expectations maps to EU AI Act (Adjacent)
Approved AI Systems (Company Policy) Approved AI Systems (Company Policy) maps to FDA Draft AI Guidance — Approved AI Systems (Company Policy) maps to FDA–EMA Good AI Practice Principles Approved AI Systems (Company Policy) maps to EMA Reflection Paper — Approved AI Systems (Company Policy) maps to EU AI Act (Adjacent)
Data Privacy & Confidentiality Data Privacy & Confidentiality maps to FDA Draft AI Guidance Data Privacy & Confidentiality maps to FDA AI-Enabled Devices Guidance Data Privacy & Confidentiality maps to FDA–EMA Good AI Practice Principles Data Privacy & Confidentiality maps to EMA Reflection Paper — Data Privacy & Confidentiality maps to EU AI Act (Adjacent)
Risk Assessment & Risk Recognition Risk Assessment & Risk Recognition maps to FDA Draft AI Guidance Risk Assessment & Risk Recognition maps to FDA AI-Enabled Devices Guidance Risk Assessment & Risk Recognition maps to FDA–EMA Good AI Practice Principles Risk Assessment & Risk Recognition maps to EMA Reflection Paper Risk Assessment & Risk Recognition maps to ICH M15 (Model-Informed Drug Development) Risk Assessment & Risk Recognition maps to EU AI Act (Adjacent)
Context of Use Context of Use maps to FDA Draft AI Guidance — Context of Use maps to FDA–EMA Good AI Practice Principles Context of Use maps to EMA Reflection Paper Context of Use maps to ICH M15 (Model-Informed Drug Development) Context of Use maps to EU AI Act (Adjacent)
Human Accountability & Oversight Human Accountability & Oversight maps to FDA Draft AI Guidance Human Accountability & Oversight maps to FDA AI-Enabled Devices Guidance Human Accountability & Oversight maps to FDA–EMA Good AI Practice Principles Human Accountability & Oversight maps to EMA Reflection Paper — Human Accountability & Oversight maps to EU AI Act (Adjacent)
Prompt Engineering for GxP — — Prompt Engineering for GxP maps to FDA–EMA Good AI Practice Principles Prompt Engineering for GxP maps to EMA Reflection Paper — Prompt Engineering for GxP maps to EU AI Act (Adjacent)
AI Validation Awareness (Model Credibility) AI Validation Awareness (Model Credibility) maps to FDA Draft AI Guidance AI Validation Awareness (Model Credibility) maps to FDA AI-Enabled Devices Guidance AI Validation Awareness (Model Credibility) maps to FDA–EMA Good AI Practice Principles AI Validation Awareness (Model Credibility) maps to EMA Reflection Paper AI Validation Awareness (Model Credibility) maps to ICH M15 (Model-Informed Drug Development) AI Validation Awareness (Model Credibility) maps to EU AI Act (Adjacent)
Documentation & Audit Trails Documentation & Audit Trails maps to FDA Draft AI Guidance Documentation & Audit Trails maps to FDA AI-Enabled Devices Guidance Documentation & Audit Trails maps to FDA–EMA Good AI Practice Principles Documentation & Audit Trails maps to EMA Reflection Paper Documentation & Audit Trails maps to ICH M15 (Model-Informed Drug Development) Documentation & Audit Trails maps to EU AI Act (Adjacent)
Inspection Readiness Inspection Readiness maps to FDA Draft AI Guidance Inspection Readiness maps to FDA AI-Enabled Devices Guidance Inspection Readiness maps to FDA–EMA Good AI Practice Principles Inspection Readiness maps to EMA Reflection Paper — Inspection Readiness maps to EU AI Act (Adjacent)
AI Incident Reporting & Response AI Incident Reporting & Response maps to FDA Draft AI Guidance AI Incident Reporting & Response maps to FDA AI-Enabled Devices Guidance AI Incident Reporting & Response maps to FDA–EMA Good AI Practice Principles AI Incident Reporting & Response maps to EMA Reflection Paper AI Incident Reporting & Response maps to ICH M15 (Model-Informed Drug Development) AI Incident Reporting & Response maps to EU AI Act (Adjacent)
Role-Based Certification & Competency Role-Based Certification & Competency maps to FDA Draft AI Guidance — Role-Based Certification & Competency maps to FDA–EMA Good AI Practice Principles Role-Based Certification & Competency maps to EMA Reflection Paper Role-Based Certification & Competency maps to ICH M15 (Model-Informed Drug Development) Role-Based Certification & Competency maps to EU AI Act (Adjacent)

Packages are built around the roles you need covered

Request training for the roles that need it. QA and Validation carry the heaviest load; Operators and Executives need a leaner, targeted set. You are not paying for content your team doesn’t use.

Request a Readiness Assessment