| name | design-training-program |
| locale | caveman |
| source_locale | en |
| source_commit | 82c77053 |
| translator | Julius Brussee homage — caveman |
| translation_date | 2026-04-24 |
| description | Design a GxP training programme covering training needs analysis by role, curriculum design (regulatory awareness, system-specific, data integrity), competency assessment criteria, training record retention, and retraining triggers for SOP revisions and incidents. Use when a new validated system requires user training before go-live, an audit finding cites inadequate training, organisational changes introduce new roles, a periodic programme review is due, or inspection preparation requires demonstrating training adequacy.
|
| license | MIT |
| allowed-tools | Read Write Edit Bash Grep Glob |
| metadata | {"author":"Philipp Thoss","version":"1.0","domain":"compliance","complexity":"intermediate","language":"multi","tags":"gxp, training, competency, compliance, quality-management, curriculum"} |
Design Training Program
Role-based GxP training programme. Curriculum, competency assessments, record management for regulated env.
When Use
- New validated system needs user training before go-live
- Audit finding cites bad training or missing training records
- Org changes bring new roles or responsibilities
- Periodic review of training programme due
- Regulatory inspection prep needs proof of training adequacy
Inputs
- Required: Systems + processes needing trained personnel
- Required: Role definitions (admin, user, QA, management)
- Required: Regulatory training requirements (GMP, GLP, GCP)
- Optional: Existing training materials or curricula
- Optional: Competency gaps from audits or perf reviews
- Optional: Training management system capabilities
Steps
Step 1: Do Training Needs Analysis
Find what each role needs to know:
# Training Needs Analysis
## Document ID: TNA-[DEPT]-[YYYY]-[NNN]
### Role-Based Training Requirements
| Role | GxP Awareness | System Training | Data Integrity | SOP Training | Assessment Type |
|------|--------------|----------------|----------------|--------------|-----------------|
| System Administrator | Advanced | Advanced | Advanced | Admin SOPs | Written + Practical |
| End User | Basic | Intermediate | Intermediate | Operational SOPs | Written + Practical |
| QA Reviewer | Advanced | Basic (review focus) | Advanced | QA SOPs | Written |
| Management | Basic | Overview only | Intermediate | Governance SOPs | Written |
| IT Support | Basic | Infrastructure only | Basic | IT SOPs | Written |
### Training Gap Analysis
| Role | Current Competency | Required Competency | Gap | Priority |
|------|-------------------|---------------------|-----|----------|
| [Role] | [Current level] | [Required level] | [Gap description] | [H/M/L] |
Got: Every role has training needs linked to job function + GxP responsibilities.
If fail: Roles unclear? Do RACI first. Set responsibilities before training needs.
Step 2: Design Curriculum
Break training into modules by topic:
# Training Curriculum
## Document ID: TC-[DEPT]-[YYYY]-[NNN]
2 hours | Classroom / eLearning | All roles
Introduction to GxP regulations (GMP, GLP, GCP overview)
21 CFR Part 11 and EU Annex 11 requirements for electronic records
Data integrity principles (ALCOA+)
Consequences of non-compliance (warning letters, consent decrees, product recalls)
Individual responsibilities and accountability
4 hours | Instructor-led with hands-on | Users, Admins
System purpose and GxP classification
Login, navigation, and role-based access
Core workflows (step-by-step for each user task)
Electronic signature procedures
Audit trail: how entries are created and what they mean
Error handling and deviation reporting
Data entry best practices
1.5 hours | Workshop | Users, QA, Admins
ALCOA+ principles with system-specific examples
Common data integrity risks and how to avoid them
Recognising and reporting data integrity concerns
Audit trail review basics
Case studies: real-world data integrity failures and lessons learned
1 hour per SOP | Read and sign / walkthrough | Per SOP scope
SOP purpose and scope
Step-by-step procedure walkthrough
Decision points and deviation handling
Forms and documentation requirements
Q&A and clarification
