Fundamentals Series

The Fundamentals of Good Laboratory Practices (OECD)

Behind every transformative biopharmaceutical therapy lies an unyielding commitment to scientific truth, where rigorous non-clinical safety testing acts as the ultimate protective shield for trial volunteers and future patients. When non-clinical safety studies fail due to unaddressed contamination or altered raw data, the downstream risks to human health and institutional credibility are profound. This course connects daily laboratory precision with global health protection by demonstrating how adherence to OECD Good Laboratory Practice guarantees the absolute reproducibility and transparency of toxicity data. By embedding real-time ALCOA+ data integrity habits and leveraging the Mutual Acceptance of Data (MAD) framework, learners discover how robust laboratory governance directly defends patient safety, accelerates time-to-market for life-saving treatments, and upholds public trust in scientific innovation.

CEU Credits: 0.1
Course Code: ELM-223
Duration: 20 mins
Skill Level: Basic
Final Exam: Yes
Certification: Yes
Version: v3.0
Effective Date: 09/29/2026

Curriculum for this course

Course Introduction
What Is GLP?
Classify that Study!
The Global Regulatory Framework & OECD Alignment
Mutual Acceptance of Data (MAD)
Get Ready to Investigate
Section 1: Test Facility Organisation and Personnel
Section 1: Study Director and PI
Section 2: Quality Assurance Programme
Audit Time!
Section 3: Facilities
Section 4: Apparatus, Material, and Reagents
Lab Bench Audit
Section 5: Test Systems
Biological Test System Audit
Section 6: Test and Reference Items
Game Time: Test Item or Test System?
Section 6 Records and Documentation Requirements
Test & Reference Items Audit
Section 7: Standard Operating Procedures
SOPs at CornerCut
Section 8: Performance of the Study
Section 8: Study Plan Amendments and Deviations
The ALCOA+ Framework
Data Integrity at CornerCut
Section 9: Reporting of Study Results
CornerCut’s Final Report
Section 10: Storage and Retention of Records and Materials
Study Resolution
Test Your Knowledge
v3.0 | This course has been redesigned. The redesign aligns the learning objectives and content to the OECD Principles of Good Laboratory Practice. The visual design has also been updated.
v2.2 | Minor update on 8/24/2026 Link in Resources updated. Course content has not been changed.
v2.1 | Minor update on 02/07/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v2.0 | This course has been redesigned on 09/13/2024. The redesign includes updated learning objectives and content. The visual design has also been updated.
v1.4 | Minor update on 07/10/23 to improve course functionality
v1.3 | Minor update on 02/21/2023 to improve course functionality.
v1.2 | Minor update on 01/17/2023 to fix assessment functionality, improve navigation, and update to current standards.
v1.1 | Minor update on 11/23/2022 to improve video playback
v1.0 | Course Released on 11/18/2022

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