GxP

This course provides a practical introduction to 21 CFR Part 11 requirements governing electronic records and electronic signatures in FDA-regulated environments. It explains the scope, applicability, and key compliance principles, including system validation, data integrity, audit trails, and security controls. The course also introduces the FDA’s Bioresearch Monitoring (BIMO) Program, outlining its role in ensuring the integrity of clinical and nonclinical research data. Learners will gain a clear understanding of regulatory expectations and how to maintain compliance in real-world settings.

  Welcome to the OECD Good Laboratory Practices (GLP) Course! The OECD Principles of Good Laboratory Practice (GLP) establish quality standards for the organization and execution of non-clinical safety studies on chemicals. They define the responsibilities of personnel, facilities, and record-keeping to ensure the generation of reliable and credible test data. GLP also supports international harmonization and the mutual acceptance of safety data among countries. This course serves as a comprehensive introduction to the principles and practical applications of OECD Good Laboratory Practices (GLP). Through a well-structured and engaging format, you will learn the core concepts that underpin GLP and understand how they are implemented in laboratory and testing environments. In addition to technical requirements, the course highlights the critical role of non-clinical safety studies in regulatory approvals and their wider importance in protecting human health and the environment. Suitable for learners at all levels, the course provides meaningful insights for both those new to GLP and professionals looking to strengthen their existing knowledge.