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.
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:
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
| Regulatory Authority | Framework | Application |
|---|---|---|
| European Commission | Directive 2004/9/EC | GLP inspections, reporting, and internal market requirements |
| European Commission | Directive 2004/10/EC | Implementation of OECD Principles of GLP |
| OECD | OECD Principles of GLP (as revised in 1997) | Mutual Acceptance of Data (MAD) |
| National Authorities | Member State GLP Compliance Monitoring Programmes | Inspection and enforcement) |
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.
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.
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.
Enroll in GLP Internal Auditor Certification (OECD Focused)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.
Enroll in GLP Internal Auditor Certification (FDA Focused)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.
Enroll in ISO 19011:2026GLP training is essential for all personnel involved in the generation, management, and regulatory submission of non clinical safety data in the EU.
EU Member State competent authorities, designated under Directive 2004/9/EC, conduct GLP inspections of test facilities. Inspection findings can have serious consequences:
| Feature | GxP Trainings |
|---|---|
| EU Directives 2004/9/EC & 2004/10/EC aligned | |
| OECD Principles of GLP aligned | |
| 21 CFR Part 58 (FDA GLP) covered | |
| ISO 19011 auditing principles covered | |
| 21 CFR Part 11 compliant certificate | |
| Self paced — study on your schedule | |
| Instant certificate download | |
| Verifiable certificate ID | |
| Group / corporate enrollment |
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.
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.
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.
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
All courses include lifetime access — study at your own pace, on your own schedule.
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Equip yourself and your team with the GLP knowledge and documented training records required for MHRA, EMA, and FDA inspection readiness.