Description

This comprehensive training program offers an in-depth examination of the OECD Principles of Good Laboratory Practice (GLP), as revised in 1997. Tailored for professionals in the pharmaceutical, chemical, and biotechnology sectors, the curriculum addresses the complete range of GLP requirements, including organizational responsibilities, quality assurance, study conduct, data integrity, and archival management. The program equips participants with practical knowledge of how GLP facilitates the production of reliable, reproducible, and internationally recognized non-clinical safety data, thereby supporting regulatory compliance, safeguarding human health, and enabling the Mutual Acceptance of Data (MAD) in global markets.

Intended Audience

This training program is intended for professionals engaged in the generation, management, and regulatory submission of non-clinical safety data, including the following roles:

• Laboratory Technicians and Study Personnel: Individuals responsible for conducting hands-on activities in safety studies
• Study Directors and Principal Investigators: Personnel accountable for the overall and delegated conduct of studies
• Quality Assurance (QA) Professionals: Individuals tasked with monitoring compliance with GLP principles
• Test Facility and Test Site Management: Individuals holding organizational authority and responsibility for GLP compliance
• Regulatory Affairs Specialists: Professionals responsible for preparing and submitting dossiers to regulatory authorities
• Sponsors: Organizations that commission or submit studies
• New Employees: Personnel in the pharmaceutical, pesticide, chemical, and biotechnology industries who require GLP orientation

International Regulatory References

This training program aligns with the following international instruments and standards:

• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1: OECD Principles on Good Laboratory Practice (as revised in 1997) – ENV/MC/CHEM (98)17
• OECD Council Act C(81)30(Final): Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals
• OECD Council Act-Recommendation C(89)87(Final): Decision-Recommendation of the Council on Compliance with Good Laboratory Practice
• OECD Council Act C(97)114/Final: Decision of the Council concerning the Adherence of Non-Member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals
• The Inter-Organization Program for the Sound Management of Chemicals (IOMC) framework, which facilitates the global implementation of OECD GLP principles in coordination with WHO, FAO, ILO, UNEP, and UNIDO

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.