Course description

This course provides detailed training on Good Laboratory Practice (GLP) as defined by the OECD, WHO, and relevant national regulatory bodies. GLP ensures the generation of reliable, reproducible, and auditable non-clinical safety data, forming the foundation for regulatory submissions in pharmaceuticals, agriculture, chemicals, and food safety. Participants will gain insights into laboratory systems, study planning, documentation, and QA oversight in GLP-compliant environments. The course prepares laboratories for GLP certification/accreditation, fosters data integrity, and enhances global acceptance of study results.

What You’ll Learn

By the end of the course, you will be able to:

• Understand the purpose, scope, and structure of OECD GLP principles

• Apply GLP requirements in study design, conduct, and reporting

• Define roles and responsibilities of key GLP personnel (Study Director, QA, Test Facility Manager)

• Establish and maintain Standard Operating Procedures (SOPs)

• Design quality management systems for laboratory operations

• Implement data integrity controls (ALCOA+ principles)

• Manage laboratory instruments, calibrations, and validations

• Develop archiving and document retention systems

• Prepare for GLP audits, inspections, and corrective actions

• Align GLP practices with GxP systems (GMP, GCP, ISO 17025)

Who Should Attend

• Laboratory Managers and Analysts

• Study Directors and Principal Investigators

• Quality Assurance Personnel

• R&D and Preclinical Testing Teams

• Regulatory Affairs and Compliance Officers

• Environmental, Food, and Agrochemical Testing Labs

• CROs and Contract Testing Facilities

• Professionals preparing for GLP inspection or accreditation

Recommended

• No prior GLP training required

• Suitable for labs in pharmaceuticals, chemicals, food safety, and veterinary products

• Strongly recommended before regulatory submissions involving non-clinical data