Good Laboratory Practice (GLP) Compliance Program
$ 150
Provides comprehensive training in Good Laboratory Practice standards as applied in non-clinical safety studies to ensure data quality and integrity.
Course Description
This program provides comprehensive training in Good Laboratory Practice standards as applied in non-clinical safety studies. Participants learn the organizational processes and conditions required to ensure the quality, integrity, and traceability of non-clinical research data in compliance with OECD GLP Principles.
Program Modules
- Introduction to GLP: OECD Principles, History & Regulatory Basis
- Test Facility Organization: Management, Quality Assurance Unit & Roles
- Standard Operating Procedures: Writing, Approval & Management
- Study Plans, Protocols & Experimental Design in GLP Studies
- Test Article & Reference Substance Characterization & Accountability
- Equipment Qualification, Calibration & Maintenance Records
- Data Integrity: ALCOA+ Principles, Raw Data Management & Archiving
- GLP Inspections, Audit Findings & Non-Compliance Management
Who Should Attend
Laboratory scientists conducting non-clinical safety studies, quality assurance officers, study directors, research managers, and regulatory affairs professionals in pharmaceutical, chemical, and contract research organizations.
Course Details
- Duration: 4 Days
- Investment: $150 per participant