Comprehensive online GLP Internal Auditor training aligned with FDA 21 CFR Part 58, OECD Principles of GLP, and ISO 19011 auditing standards — trusted by US pharmaceutical, biotechnology, and chemical professionals. Self paced. 21 CFR Part 11 compliant certificates. Inspection ready training records.
The United States has a comprehensive regulatory framework for Good Laboratory Practice (GLP) that is primarily governed by the FDA's regulations in 21 CFR Part 58. These regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures, test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification.
Key Regulatory Frameworks:
Good Laboratory Practices (GLP) under 21 CFR 58 applies to nonclinical laboratory studies (safety studies) that are intended to support applications for research and marketing permits including Investigational Device Exemption and Premarket Approval applications
Compliance with GLP is intended to ensure the quality and integrity of safety data obtained from animal studies submitted to FDA
If information on nonclinical laboratory studies is provided in the IDE application, a statement that all such studies have been conducted in compliance with GLP regulations must be provided
| Regulatory Authority | Framework | Application |
|---|---|---|
| FDA | 21 CFR Part 58 | Nonclinical laboratory studies supporting FDA applications |
| Nonclinical laboratory studies supporting FDA applications | 21 CFR Part 11 | Electronic records and signatures |
| OECD | OECD Principles of GLP (as revised in 1997) | Mutual Acceptance of Data (MAD) |
| OECD | OECD | GLP for pesticide and chemical testing |
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 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. The participant learns both what GLP requires and how to plan, execute, report, and close internal audits of those requirements.
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.
Enroll in Good Laboratory Practices (OECD Focused)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 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 Auditor Certification is essential for personnel responsible for auditing nonclinical laboratory testing facilities.
The FDA conducts inspections of nonclinical laboratories to ensure compliance with 21 CFR Part 58. The FDA has implemented a program of regular inspections and data audits to monitor laboratory compliance with the GLP requirements. Inspection findings can have serious consequences:
| Feature | GxP Trainings |
|---|---|
| FDA 21 CFR Part 58 aligned | |
| FDA 21 CFR Part 58 aligned | |
| 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. The FDA does 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 FDA inspectors accept during inspections.
The FDA Focused course is based on 21 CFR Part 58, which is specific to FDA requirements. The OECD Focused course is based on the OECD Principles of GLP (as revised in 1997), which are applicable internationally. 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.