GLP Training in the USA

Good Laboratory Practices for Nonclinical Safety Studies

Comprehensive online GLP 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.

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

Regulatory Context

GLP Compliance in the USA: FDA 21 CFR Part 58 & International Standards

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:

Key Requirements:

• 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
• If any study was not conducted in compliance with the GLP regulations, a brief statement of the reason for the noncompliance must be provided

The FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58, on December 22, 1978, and they became effective June 1979.

Our Courses

GLP Training Courses — FDA 21 CFR Part 58 & 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 FDA and other regulatory inspections.

Most Popular for US GLP Professionals

Good Laboratory Practices (FDA Focused)

Price: $149.00

This training program provides comprehensive instruction on the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations, codified as 21 Code of Federal Regulations (CFR) Part 58. The program transforms regulatory requirements into practical knowledge applicable to nonclinical laboratory operations.

The program begins with the historical context that led to the establishment of GLP regulations, a period marked by significant data integrity failures that undermined public trust and the scientific process. From this foundation, the program systematically builds knowledge across the entire lifecycle of a nonclinical laboratory study, covering organizational structure, facility design, equipment management, standard operating procedures, test article handling, protocol development, study conduct, data management, quality assurance, reporting, and enforcement consequences.

Each module contains detailed content explaining regulatory requirements and their practical application, followed by learning objectives and assessment questions with answer justifications. The eleven modules are designed to be completed in sequence, as later modules reference concepts introduced in earlier sections.

Global Regulatory References:
This training program is based primarily on the following regulation:

The principles and requirements presented in this program are consistent with and informed by the following international guidance documents:

Target Audience:
This training program is designed for professionals involved in the conduct, management, oversight, or auditing of nonclinical laboratory studies:

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

Curriculum: 11 Sections – 11 Lessons – Lifetime Access

Enroll in Good Laboratory Practices (FDA Focused)

FDA GLP Training | 21 CFR Part 58 Certification | GxP Trainings

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

Learning Objectives:

• Interpret and apply all 21 CFR Part 58 GLP requirements to nonclinical laboratory operations
• 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 GLP risks
• 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
• Track CAPA using a formal CAPA tracking log with status codes
• Verify effectiveness of corrective and preventive actions

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

Additional GLP Training Courses

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.

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

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
• Quality Assurance Programme
• Facilities
• Apparatus, Material and Reagents
• Test Systems
• Test and Reference Items
• Standard Operating Procedures
• Performance of the Study
• Reporting of Study Results
• Storage and Retention of Records and Materials
• Multi‑Site Study Management
• Auditing practices

Target Audience:

• Quality Assurance 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

OECD GLP Internal Auditor Certification Course | GxP Trainings

OECD GLP Internal Auditor Certification Course | GxP Trainings

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 USA?

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

Laboratory Personnel

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

Quality & Compliance

• Quality Assurance (QA) Unit Personnel
• 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

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:

• FDA Warning Letters — published publicly and can damage reputation
• Data rejection — non‑compliant study data may not be accepted in FDA submissions
• Disqualification — laboratories can be disqualified from conducting GLP studies
• Legal action — including fines and criminal prosecution

Common FDA 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 FDA 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 FDA inspectors
• Satisfies 21 CFR Part 58 personnel training requirements

Why Choose GxP Trainings for GLP

Frequently Asked Questions

Q: Is online GLP training accepted by the FDA?
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.

Q: What is the difference between the FDA Focused and OECD Focused GLP courses?
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 GLP 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 US 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/

US GLP Compliance Summary

The US regulatory framework for GLP is primarily governed by 21 CFR Part 58, which specifies minimum standards for the proper conduct of safety testing.

21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies

The FDA promulgated the GLP Regulations, 21 CFR Part 58, on December 22, 1978, and they became effective June 1979.

Key Subparts:

• Subpart A – General Provisions: Scope, definitions, applicability
• Subpart B – Organisation and Personnel: Test facility management, study director, quality assurance unit, personnel
• Subpart C – Facilities: Animal care facilities, test article handling facilities, laboratory operation areas, specimen and data storage facilities
• Subpart D – Equipment: Equipment design, maintenance, calibration, and inspection
• Subpart E – Testing Facilities Operation: Standard operating procedures, reagents and solutions, animal care
• Subpart F – Test and Control Articles: Characterization, handling, and mixtures with carriers
• Subpart G – Protocol for and Conduct of a Nonclinical Laboratory Study: Protocol approval, changes, and study conduct
• Subpart J – Records and Reports: Final reporting, storage and retrieval, retention requirements
• Subpart K – Disqualification of Testing Facilities: Grounds for disqualification and procedures

Scope:
21 CFR Part 58 prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, and medical devices for human use.

All GxP Trainings courses referenced above are designed to align with FDA 21 CFR Part 58, OECD Principles of Good Laboratory Practice, and international GLP standards.