Good Laboratory Practice Foundation Course

Description

Good Laboratory Practice Foundation Course

This course provides a comprehensive introduction to Good Laboratory Practice (GLP) principles and their application in pharmaceutical and analytical laboratories. It focuses on establishing a quality system framework that ensures the reliability, reproducibility, and integrity of non-clinical laboratory data. Participants will gain an understanding of GLP requirements for personnel, documentation, equipment, study conduct, and data management in compliance with global regulatory expectations.

Key Learning Areas

• Introduction to GLP Principles
  Understanding the history, purpose, and regulatory framework of Good Laboratory Practice in pharmaceutical and non-clinical studies.
• GLP Organizational Structure & Responsibilities
  Roles and responsibilities of management, study directors, quality assurance units (QAU), and laboratory personnel.
• Documentation & Standard Operating Procedures (SOPs)
  Importance of SOPs, study plans, raw data recording, and controlled documentation systems.
• Equipment, Materials & Facility Requirements
  Qualification, calibration, maintenance of instruments, and environmental controls to ensure reliable data generation.
• Study Conduct & Data Integrity
  Proper execution of laboratory studies with emphasis on accuracy, traceability, and ALCOA+ data integrity principles.
• Quality Assurance (QA) Systems
  Role of QA in audits, inspections, study oversight, and compliance monitoring.
• Archiving & Record Management
  Proper storage, retrieval, and retention of raw data, reports, and study documentation.
• Regulatory Compliance & Inspection Readiness
  Overview of OECD GLP guidelines and regulatory expectations for laboratory inspections and audits.