GxP Training Compliance and Competency Audit Checklist
GxP training ensures personnel have the knowledge and skills to perform their duties without adverse quality impact. This audit verifies training programs meet FDA 21 CFR 211.68 and EU GMP Chapter 2 personnel requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Semi-Annual
- Estimated Time: 30-45 minutes
- Role: QA Manager / Training Manager
- Total Items: 31
- Compliance: FDA 21 CFR 211.68 - Personnel Qualifications, EU GMP Chapter 2 - Personnel, ICH Q10 Section 2.1.2 Knowledge Management, ISO 9001:2015 Section 7.2 Competence
Training Program Design
Assess training program structure and coverage.
- Training needs analysis completed for all GxP roles?
- Role-based training curricula defined for each GxP position?
- Training materials current and aligned with current SOPs?
- Comprehensive GMP orientation program for new employees?
- Periodic refresher training schedule for all GxP employees?
Training Records
Verify training record completeness and accuracy.
- Training records complete for all personnel in department?
- No employees with overdue required training?
- Training records include date, trainer, method, and assessment results?
- Electronic training management system validated if used?
- Training records retained per documentation retention schedule?
SOP and Procedure Training
Verify SOP training and qualification.
- Personnel trained on SOPs before authorized to perform procedures?
- New and revised SOPs trigger training before effective date?
- Read-and-understand acknowledgement documented for all applicable SOPs?
- On-the-job training documented with trainer and trainee signatures?
- Practical demonstration or test confirming competency documented?
GMP Awareness and Culture
Assess GMP culture and awareness.
- Annual GMP refresher training completed by all GxP personnel?
- Personnel understand consequences of GMP non-compliance on patients and regulatory action?
- Evidence of quality culture: personnel raising quality concerns proactively?
- Management demonstrating commitment to GMP through visible actions?
- Training effectiveness assessments demonstrating knowledge retention?
Critical Position Qualification
Verify critical positions are properly qualified.
- All QC analysts qualified for analytical methods they perform?
- Production operators qualified for all processes they operate?
- QA personnel qualified for batch record review and release?
- Qualified Person (QP) designated per EU GMP requirements?
- Qualified backup designated for all critical single-person roles?
Documentation and Improvement
Document training audit outcomes.
- Training gap analysis completed for department?
- Training plan to address gaps with timelines?
- Training compliance metrics reported at management review?
- Adequate training budget and resources allocated?
- Previous training audit findings addressed?
- Training audit report prepared and distributed?
Related Pharmaceutical Life Sciences Checklists
- FDA Inspection Readiness Assessment Checklist
- Pharmaceutical Product Recall Readiness Checklist
- FDA GMP Inspection Readiness Audit Checklist
- Annual Product Quality Review (APQR) Preparation Checklist
- Pharmaceutical Incoming Material Sampling and Testing Checklist
- Pharmaceutical Product Complaint Handling Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
- Pharmaceutical Product Recall Readiness Checklist
Related Regulatory Readiness Checklists
- FDA Inspection Readiness Assessment Checklist - FREE Download
- Pharmaceutical Product Recall Readiness Checklist - FREE Download
- FDA GMP Inspection Readiness Audit Checklist - FREE Download
- Annual Product Quality Review (APQR) Preparation Checklist - FREE Download
- Pharmaceutical Product Complaint Handling Checklist - FREE Download
- Pharmaceutical Product Recall Readiness Checklist - FREE Download
Why Use This GxP Training Compliance and Competency Audit Checklist?
This gxp training compliance and competency audit checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / training manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: semi-annual.
Ensures compliance with FDA 21 CFR 211.68 - Personnel Qualifications, EU GMP Chapter 2 - Personnel, ICH Q10 Section 2.1.2 Knowledge Management, ISO 9001:2015 Section 7.2 Competence. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the GxP Training Compliance and Competency Audit Checklist cover?
This checklist covers 31 inspection items across 6 sections: Training Program Design, Training Records, SOP and Procedure Training, GMP Awareness and Culture, Critical Position Qualification, Documentation and Improvement. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed semi-annual. Each completion takes approximately 30-45 minutes.
Who should use this GxP Training Compliance and Competency Audit Checklist?
This checklist is designed for QA Manager / Training Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.