Curriculum
A connected curriculum built around regulated work
13 tracks, 66 lessons and 55 mapped frameworks. Learn the concepts, practise with scenarios, record your work and complete the published badge assessments.
Informed by published FDA, EMA and international AI governance expectations. Supports workforce preparation rather than organisational certification.
ENTERPRISE CURRICULUM BLUEPRINT
Compliant AI in GMP
Two versions of the proposed enterprise curriculum and control framework
The 8-page executive brief gives sponsors the decision, pathways, evidence gates and regulatory posture. The 40-page technical blueprint contains all 19 modules, laboratories, learner and system-owner controls, qualification design and sources.
The Academy currently offers 13 tracks and 66 lessons with knowledge checks, practical exercises and recorded submissions. Both documents describe proposed enterprise work. The 19-module program, observed assessments and qualification board are not currently available as an online course.
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See how an organization can evaluate the framework →What’s included
- Executive decision briefAn 8-page version for sponsors who need the decision, operating model, proposed pathways, evidence gates and next step.
- Full 19-module blueprintThe complete technical design for role-specific learning, system controls and performance assessment. The proposed program is not available as an online course.
- Authority ladderDefined levels of AI contribution and the corresponding human obligations.
- AI failure-mode taxonomyA shared vocabulary for identifying and reviewing AI output defects.
- Proposed role pathwaysDesigns for manufacturing, QA, QC, MSAT, process development, supply chain, risk management and document control.
- Proposed assessment frameworkSpecifications for observed simulations, oral defense, critical failures and requalification. Case materials, assessor calibration and pilot evaluation remain to be developed.
- Organizational implementation roadmapPhased actions and exit evidence for putting the program into practice.
- Regulatory baselineA primary-source regulatory baseline updated on 17 September 2026.
Your pathway
General workforce user
Uses approved AI tools for day-to-day work that may touch regulated processes, documents or data.
Current stage
1 — Foundational AI Literacy
Required tracks
5
Completed tracks
0/5
Badges earned
0
Renewals due
0
Overall pathway progress
0%
Next recommended action
Start Track 01 — AI Fundamentals
Stage 1
Foundational AI Literacy
2 tracks
The learner understands AI, its life-sciences applications, its limitations, the relevant regulatory environment and the need for human governance.
Life Sciences AI Foundations Credential
Stage 2
Operational Guardrails
4 tracks
The learner can determine whether an AI tool, data input and intended use are authorized and appropriately controlled.
AI Operational Guardrails Credential
Stage 3
Applied GxP Skills
3 tracks
The learner can use AI under human control, create source-grounded prompts, review outputs and recognize model-credibility requirements.
Applied GxP AI Practitioner Credential
Stage 4
Compliance Infrastructure
3 tracks
The learner can document AI-assisted work, support inspection readiness and respond appropriately to AI incidents.
AI Compliance and Inspection Readiness Credential
Stage 5
Role-Based Capstone
1 track
The learner demonstrates the integrated use of all relevant competencies through a realistic role-specific pharmaceutical scenario.
Certified Life Sciences AI Practitioner — [Role]
Stage 1 · 2 tracks
Foundational AI Literacy
The learner understands AI, its life-sciences applications, its limitations, the relevant regulatory environment and the need for human governance.
Award: Life Sciences AI Foundations Credential
Stage 2 · 4 tracks
Operational Guardrails
The learner can determine whether an AI tool, data input and intended use are authorized and appropriately controlled.
Award: AI Operational Guardrails Credential
Stage 3 · 3 tracks
Applied GxP Skills
The learner can use AI under human control, create source-grounded prompts, review outputs and recognize model-credibility requirements.
Award: Applied GxP AI Practitioner Credential
Stage 4 · 3 tracks
Compliance Infrastructure
The learner can document AI-assisted work, support inspection readiness and respond appropriately to AI incidents.
Award: AI Compliance and Inspection Readiness Credential
Stage 5 · 1 track
Role-Based Capstone
The learner demonstrates the integrated use of all relevant competencies through a realistic role-specific pharmaceutical scenario.
Award: Certified Life Sciences AI Practitioner — [Role]
How the workflow runs
Ten steps from diagnostic to maintained competency
- 01
Readiness assessment
A nine-part diagnostic covering role, AI experience, GxP responsibility, decision authority, data handled, tools used, prior training, risk confidence and regulatory duties.
Take the diagnostic → - 02
Role-based pathway
Required, recommended and optional tracks for your role, with estimated time, available badges, prerequisites and current progress.
See your pathway → - 03
Track orientation
Before a track opens: why it matters, what you will be able to do, the frameworks it maps to, time required, prerequisites, badge requirements and a short pharmaceutical scenario.
- 04
Learn
Each lesson runs an eight-part sequence — workplace problem, governing concept, pharmaceutical example, correct and incorrect behaviour, your decision, explanatory feedback, knowledge check, and the bridge to the next competency.
- 05
Practice
Every lesson carries a realistic exercise — classify an AI use, spot sensitive information, detect a fabrication, verify citations, write a context of use, rank risk, select controls, build an audit trail, answer an inspector, report an incident. You work it in the lesson, tick off each piece of expected evidence and describe what you did; that record, not a tick-box, satisfies the practical gate in the badge standard.
- 06
Verify knowledge
Seven question types with explanatory feedback on every option — multiple choice, select all, scenario classification, ordering, matching a control to a risk, identifying the unsupported statement and choosing the escalation path.
- 07
Performance assessment
A badge requires all required lessons, at least 80% overall, every safety-critical question correct, recorded evidence for every practical exercise, documentation demonstrated and the correct escalation pathway. Reassessment follows remediation.
- 08
Badge award
Badge title, learner identity, issue and renewal dates, competencies demonstrated, curriculum version, assessment standard, issuing organization, verification identifier and the regulatory-alignment disclaimer.
Badge records → - 09
Role-based capstone
Track 13 puts the whole pathway together in a thirteen-step end-to-end scenario, from receiving the request to closing the record and setting the maintenance obligation.
View the capstone → - 10
Continuing competency
Annual refreshers, regulatory-update microlearning, policy-update training, incident-driven retraining, badge renewal, competency reassessment and a published curriculum-version history.
Maintenance obligations →
Step 10
Maintaining competency
A badge records competency on the date it was demonstrated. These obligations keep it meaningful afterwards, and every one of them is visible to the learner before they start.
Annual refresher assignment
Every 12 monthsA condensed replay of the safety-critical content in every track the learner holds a badge for, assigned twelve months after the badge issue date.
Regulatory-update microlearning
On framework changeShort modules issued when a mapped framework publishes a material change, so that badge holders stay aligned with current published expectations.
Company-policy update training
On policy changeIssued when the organization changes its approved-tool list, data-classification rules or escalation routes.
Incident-driven retraining
On incidentTriggered by a recorded AI incident, deviation or near miss involving the learner's function; targets the competency the event exposed.
Badge renewal
Every 12 monthsBadges carry a renewal date. Renewal requires the refresher plus a reduced-length competency reassessment.
Competency reassessment
Every 24 months or on role changeA full reassessment of the role capstone, required every two years or after a change of role.
Curriculum version history
- 2026.12026-01-15
Five-stage progressive architecture introduced. All thirteen tracks aligned to the Understand / Apply / Verify / Document / Escalate behavioral framework, with role-based pathways and badge-level safety-critical gating.
- 2025.22025-07-01
Tracks 03–13 expanded from outline to full lesson structure. Context-of-use and incident-response content separated into dedicated tracks.
- 2025.12025-02-10
Initial release of Tracks 01–02 with credential detail, exercises and badge assessment.
Badges record the curriculum version under which they were earned. See your badge records.
Regulatory alignment indicates that curriculum topics map to published regulatory expectations. It does not constitute agency approval, certification, legal advice or a determination of organizational compliance.