Training on Good Laboratory Practice (GLP)

This training provides participants with a comprehensive understanding of Good Laboratory Practice (GLP) principles and their application in laboratory environments. It focuses on quality systems, standard operating procedures, data integrity, and regulatory compliance to ensure reliable and reproducible laboratory results. Participants will gain practical skills for managing laboratory operations, documentation, and audits in line with international standards such as OECD GLP and ISO/IEC 17025. The course emphasizes both technical and managerial perspectives to build a culture of quality and accountability in laboratory settings.

Duration

5 Days

Who Should Attend

• Laboratory Managers and Supervisors

• Quality Assurance and Quality Control Officers

• Research Scientists and Technicians

• Regulatory Affairs Professionals

• Auditors and Compliance Officers in testing and research environments

Organization Impact:

• Strengthens laboratory credibility and trust through compliance with international standards.

• Enhances data reliability, consistency, and reproducibility.

• Reduces audit failures and improves regulatory readiness.

• Builds a sustainable culture of quality, safety, and accountability.

Individual Impact:

• Develops expertise in implementing and maintaining GLP systems.

• Improves competence in laboratory quality assurance and compliance.

• Enhances professional credibility in regulated environments.

• Expands career opportunities in research, testing, and regulatory industries.

By the end of this course, participants will be able to:

• Understand the principles and purpose of GLP.

• Implement effective quality management systems in laboratories.

• Maintain accurate documentation and traceability of experimental data.

• Ensure compliance with OECD, WHO, and ISO standards.

• Prepare for and manage internal and external laboratory audits.

Module 1: Introduction to Good Laboratory Practice

• History, scope, and objectives of GLP.

• The role of GLP in research and regulatory compliance.

• International frameworks: OECD, WHO, and ISO standards.
  Case Study: Implementing GLP in a newly accredited testing laboratory.

Module 2: Quality Systems and Organizational Structure

• Essential components of a laboratory quality system.

• Roles and responsibilities under GLP.

• Quality assurance versus quality control.

• Establishing a quality culture and accountability.
  Case Study: Strengthening QA systems to reduce non-conformities in laboratory audits.

Module 3: Standard Operating Procedures (SOPs) and Documentation

• Developing, maintaining, and controlling SOPs.

• Data recording, integrity, and traceability requirements.

• Managing deviations, errors, and corrective actions.

• Record retention and archiving protocols.
  Case Study: Managing documentation errors during a regulatory inspection.

Module 4: Equipment, Materials, and Calibration Management

• Equipment validation, calibration, and maintenance schedules.

• Supplier and material qualification processes.

• Environmental monitoring and control in laboratory operations.
  Case Study: Addressing calibration failures to maintain GLP compliance.

Module 5: GLP Compliance, Inspections, and Audits

• Preparing for GLP inspections and audits.

• Handling non-compliance findings and corrective actions.

• Continuous improvement in laboratory quality systems.

• Integrating risk management into laboratory operations.
  Case Study: Lessons learned from an OECD GLP compliance inspection.