GLP Training in the EU

Good Laboratory Practices for Nonclinical Safety Studies

Comprehensive online GLP training aligned with EU Directives 2004/9/EC and 2004/10/EC, OECD Principles of GLP, and international standards — trusted by European pharmaceutical, chemical, and biotechnology professionals. Self‑paced. 21 CFR Part 11 compliant certificates. Inspection‑ready training records.

5+ GLP Courses | 21 CFR Part 11 Compliant Certs | 4+ Regulatory Frameworks | EU & OECD Aligned

Regulatory Context

GLP Compliance in the EU: Directives, OECD & International Standards

The European Union has a comprehensive regulatory framework for Good Laboratory Practice (GLP) that is based on the OECD Principles of GLP and implemented through two key directives. The EU adopted GLP regulations in 1987, with amendments following the OECD in 1999.

Key Regulatory Frameworks:

Key Requirements:

• Directive 2004/9/EC obliges EU countries to designate the authorities responsible for GLP inspections in their territory
• Directive 2004/10/EC requires EU countries to take all measures necessary to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of Good Laboratory Practice
• The GLP Directives also apply to Iceland, Liechtenstein, and Norway
• The OECD Revised Guides for Compliance Monitoring Procedures for GLP must be followed during laboratory inspections and study audits

The EU has concluded Mutual Recognition Agreements on GLP with Israel, Japan, and Switzerland. Data generated in accordance with OECD GLP principles is accepted in other OECD member countries through the Mutual Acceptance of Data (MAD) system.

Our Courses

GLP Training Courses — EU & OECD Aligned

All courses are self‑paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during EMA, MHRA, and other regulatory inspections.

Most Popular for EU GLP Professionals

Good Laboratory Practices (OECD Focused)

Price: $149.00

This comprehensive training program offers an in‑depth examination of the OECD Principles of Good Laboratory Practice (GLP), as revised in 1997. Tailored for professionals in the pharmaceutical, chemical, and biotechnology sectors, the curriculum addresses the complete range of GLP requirements, including organizational responsibilities, quality assurance, study conduct, data integrity, and archival management.

The program equips participants with practical knowledge of how GLP facilitates the production of reliable, reproducible, and internationally recognized non‑clinical safety data, thereby supporting regulatory compliance, safeguarding human health, and enabling the Mutual Acceptance of Data (MAD) in global markets.

International Regulatory References:

• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1: OECD Principles on Good Laboratory Practice (as revised in 1997) – ENV/MC/CHEM (98)17
• OECD Council Act C(81)30(Final): Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals
• OECD Council Act‑Recommendation C(89)87(Final): Decision‑Recommendation of the Council on Compliance with Good Laboratory Practice
• EU Directive 2004/9/EC and Directive 2004/10/EC

Target Audience:

• Laboratory Technicians and Study Personnel
• Study Directors and Principal Investigators
• Quality Assurance (QA) Professionals
• Test Facility and Test Site Management
• Regulatory Affairs Specialists
• Sponsors
• New Employees in pharmaceutical, pesticide, chemical, and biotechnology industries

Certification:
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.

Curriculum: 12 Sections – 12 Lessons – Lifetime Access

Enroll in Good Laboratory Practices (OECD Focused)

OECD Good Laboratory Practice (GLP) Training | GxP Trainings

GLP Internal Auditor Certification (OECD Focused)

Price: $599.00

This training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in the OECD Principles of Good Laboratory Practice (as revised in 1997) . The program integrates GLP requirements for single‑site and multi‑site studies with internal auditing practices based on ISO 19011.

Operational areas covered:

• Test Facility Organisation and Personnel – test facility management responsibilities, Study Director responsibilities, Principal Investigator responsibilities (for multi‑site studies), study personnel responsibilities
• Quality Assurance Programme – independence from study conduct, study‑based inspections, facility‑based inspections, process‑based inspections, QA statement in final report
• Facilities – general requirements, test system facilities, facilities for handling test and reference items, archive facilities, waste disposal
• Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management
• Test Systems – physical/chemical systems, biological systems (animals, plants), acclimatisation, isolation, health evaluation
• Test and Reference Items – receipt, handling, sampling, storage, characterisation, stability, homogeneity, batch retention
• Standard Operating Procedures – availability, approval, deviations, historical file
• Performance of the Study – study plan, study plan amendments, study plan deviations, conduct of the study, raw data recording, data changes, audit trails
• Reporting of Study Results – final report content, QA statement, Study Director signature, amendments
• Storage and Retention of Records and Materials – archives, retention periods, indexing, access control
• Multi‑Site Study Management – Principal Investigator role, communication, master schedule, study plan for multi‑site studies, delegation of phases
• Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure

Learning Objectives:

• Interpret and apply all OECD Principles of GLP to single‑site and multi‑site nonclinical laboratory studies
• Understand and apply the seven quality management principles in the context of GLP
• Plan, manage, and execute internal audits in full accordance with auditing guidelines
• Develop audit checklists, sampling plans, and audit protocols tailored to OECD GLP requirements
• Collect objective evidence through interviews, observation, and document review
• Identify and classify non‑conformities as major, minor, or observation with clear justification
• Write non‑conformity reports that are factual, complete, and actionable
• Prepare and distribute audit reports to appropriate management levels
• Notify management of critical findings using escalation procedures
• Track CAPA using a formal CAPA tracking log with status codes
• Verify the effectiveness of corrective and preventive actions
• Close an audit properly with a closure memo and management acknowledgment
• Understand the unique requirements of multi‑site studies

Target Audience:

• Quality Assurance Personnel
• Internal Auditors (both existing and prospective)
• Study Directors
• Testing Facility Management
• Archivists
• Laboratory Supervisors
• Sponsor Representatives

Prerequisites:

• Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience
• At least six months of experience in a nonclinical laboratory testing facility

Enroll in GLP Internal Auditor Certification (OECD Focused)

OECD GLP Internal Auditor Certification Course | GxP Trainings

Additional GLP Training Courses

GLP Internal Auditor Certification (FDA Focused)

Price: $599.00

This self‑study training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in 21 CFR Part 58. The program integrates GLP requirements for nonclinical laboratory studies with internal auditing practices based on ISO 19011.

Operational areas covered:

• Facilities – animal care areas, animal supply areas, test and control article handling areas, laboratory operation areas, specimen and data storage facilities
• Equipment – design, maintenance, calibration, and inspection requirements
• Testing facility operations – standard operating procedures, reagents and solutions, animal care
• Test and control articles – characterization, handling, and mixtures with carriers
• Protocol and conduct of studies – protocol approval, changes, and study conduct
• Records and reports – final reporting, storage and retrieval, retention requirements
• Quality assurance unit – responsibilities, inspections, reporting, independence from study conduct
• Personnel and management – training, job descriptions, study director responsibilities, management obligations
• Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure

Target Audience:

• Quality Assurance Unit Personnel
• Internal Auditors
• Study Directors
• Testing Facility Management
• Archivists
• Laboratory Supervisors
• Sponsor Representatives

Prerequisites:

• Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience
• At least six months of experience in a nonclinical laboratory testing facility

Enroll in GLP Internal Auditor Certification (FDA Focused)

GLP Internal Certified Auditor (FDA Focused) I GLP Training

ISO 19011:2026 – Auditing Management Systems

Price: $199.00

This comprehensive training program is designed to provide individuals with a thorough understanding of ISO 19011:2026, “Guidelines for Auditing Management Systems.” The program covers all aspects of the standard, including the principles of auditing, managing an audit programme, conducting management system audits, and evaluating the competence of individuals involved in the audit process.

Target Audience:

• Internal Auditors
• Audit Programme Managers
• Quality Managers and Quality Professionals
• Management System Practitioners
• Second‑Party Auditors
• Consultants
• Individuals Preparing for Auditor Certification
• Top Management and Leaders

Enroll in ISO 19011:2026 – Auditing Management Systems

ISO 19011:2026 Auditor Training Course Online | GxP Trainings

Who Needs GLP Training in the EU?

GLP training is essential for all personnel involved in the generation, management, and regulatory submission of non‑clinical safety data in the EU.

Laboratory Personnel

• Laboratory Technicians and Study Personnel
• Study Directors and Principal Investigators
• Analytical Chemists and Biologists

Quality & Compliance

• Quality Assurance (QA) Professionals
• Internal Auditors
• Regulatory Affairs Specialists
• Compliance Officers

Management

• Test Facility Management
• Laboratory Supervisors
• Archivists and Data Managers

Sponsors & Contract Research Organisations

• Sponsors commissioning non‑clinical studies
• Contract Research Organisation (CRO) personnel

GLP Inspections, Compliance Risk & Training Records

What Happens When GLP Training Falls Short

EU Member State competent authorities, designated under Directive 2004/9/EC, conduct GLP inspections of test facilities. Inspection findings can have serious consequences:

• Non‑compliance statements affecting the acceptance of study data
• Rejection of study data in regulatory submissions
• Suspension or revocation of GLP compliance status
• Legal action under national laws implementing the GLP Directives

Common EU GLP inspection observations include:

• Inadequate personnel training and documentation
• Insufficient quality assurance oversight
• Poor documentation practices and data integrity issues
• Inadequate facilities and equipment maintenance

Inspection‑Ready Training Records

Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that EU inspectors accept during inspections.

• Unique verifiable certificate ID — check at gxptrainings.com/verify-certificate/
• Includes completion date, course name, and assessment score
• Downloadable PDF — upload to any QMS or LMS
• Accepted by EMA, MHRA, and other EU competent authorities
• Satisfies OECD GLP and EU Directive training requirements

Why Choose GxP Trainings for GLP

Frequently Asked Questions

Q: Is online GLP training accepted by EU regulators?
Yes. EU regulators do not mandate a specific training delivery format. What matters is that training is documented, role‑appropriate, and effective. Our 21 CFR Part 11 compliant certificates provide verifiable proof of training that EMA, MHRA, and other EU competent authorities accept during inspections.

Q: What is the difference between the OECD Focused and FDA Focused GLP Internal Auditor courses?
The OECD Focused course is based on the OECD Principles of GLP (as revised in 1997), which form the basis for EU GLP requirements. The FDA Focused course is based on 21 CFR Part 58, which is specific to FDA requirements. Both courses provide comprehensive internal auditor training.

Q: What are the prerequisites for the GLP Internal Auditor courses?
Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience, and at least six months of experience in a nonclinical laboratory testing facility.

Q: Do you offer group discounts for EU companies?
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.

Q: How long do I have access to the course?
All courses include lifetime access — study at your own pace, on your own schedule.

Q: Are the certificates verifiable?
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/

EU GLP Compliance Summary

The EU regulatory framework for GLP is based on the OECD Principles of GLP and implemented through two key directives.

Directive 2004/9/EC

Directive 2004/9/EC obliges EU countries to designate the authorities responsible for GLP inspections in their territory.

Key Requirements:

• Designation of national GLP compliance monitoring authorities
• Reporting and internal market (mutual acceptance of data) requirements
• The OECD Revised Guides for Compliance Monitoring Procedures for GLP must be followed during laboratory inspections and study audits

Directive 2004/10/EC

Directive 2004/10/EC requires EU countries to take all measures necessary to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of Good Laboratory Practice.

Key Requirements:

• Implementation of OECD Principles of GLP into national law
• Application of GLP principles to non‑clinical safety testing of test items contained in a range of products
• The GLP Directives also apply to Iceland, Liechtenstein, and Norway

Mutual Acceptance of Data (MAD)

The EU participates in the OECD Mutual Acceptance of Data (MAD) system. Data generated in accordance with OECD GLP principles is accepted in other OECD member countries, avoiding duplicative testing and reducing costs for industry and governments.

All GxP Trainings courses referenced above are designed to align with EU Directives 2004/9/EC and 2004/10/EC, OECD Principles of Good Laboratory Practice, and international GLP standards.