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.
This training program is based primarily on the following regulation:
| Regulatory Body | Regulation/Document | Title |
| U.S. Food and Drug Administration (FDA) | 21 CFR Part 58 | Good Laboratory Practice for Nonclinical Laboratory Studies |
The principles and requirements presented in this program are consistent with and informed by the following international guidance documents:
| Organization | Document/Guidance | Relevance |
| Organisation for Economic Co-operation and Development (OECD) | OECD Principles on Good Laboratory Practice (ENV/MC/CHEM(98)17) | International standard for GLP recognized by regulatory authorities worldwide, including the FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) |
| International Council for Harmonisation (ICH) | ICH Q9 – Quality Risk Management | Systematic approach to quality risk management that complements GLP requirements |
| International Council for Harmonisation (ICH) | ICH Q10 – Pharmaceutical Quality System | Quality management system model that integrates with GLP requirements |
| International Organization for Standardization (ISO) | ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| European Medicines Agency (EMA) | Directive 2004/9/EC and 2004/10/EC | European Union legislative framework for GLP inspection and enforcement |
This training program is designed for professionals involved in the conduct, management, oversight, or auditing of nonclinical laboratory studies:
| Role Category | Specific Roles |
| Study Directors | Study Director, Principal Investigator, Project Manager |
| Quality Assurance Personnel | QAU Manager, Quality Assurance Auditor, Compliance Specialist |
| Scientific and Technical Staff | Research Scientists, Laboratory Technicians, Animal Care Technicians, Pathologists, Histotechnicians |
| Testing Facility Management | Facility Director, Operations Manager, Laboratory Manager, Department Head |
| Sponsor Organizations | Sponsor Representatives, CRO Monitors, Outsourcing Managers |
| Regulatory Affairs | Regulatory Affairs Specialists, Submission Managers |
| Auditors and Inspectors | Internal Auditors, External Consultants, Regulatory Inspectors |
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
