GLP – An Introduction
Provides personnel with a foundational understanding of Good Laboratory Practice (GLP), focusing on its significance in nonclinical laboratory studies within the drug approval process. Participants will explore key concepts related to GLP, including its historical context, essential terms, and its application in ensuring the safety and integrity of drug testing. By understanding how nonclinical studies fit into the broader drug development stages—research, clinical trials, and regulatory approval—learners will appreciate the critical role GLP plays in producing reliable safety data for regulatory submissions.
Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.
Duration: 30 Mins
Grade: Core Library
Description
- Solid Understanding of GLP Principles: Develop a clear grasp of GLP regulations and their vital role in nonclinical laboratory studies, facilitating adherence to quality standards in drug development.
- Knowledge of Nonclinical Studies: Learn how nonclinical studies are designed, conducted, and monitored, ensuring safety and efficacy before human trials commence.
- Awareness of Drug Approval Process: Gain insights into the stages of drug development, including how nonclinical data influences regulatory approvals and the importance of accurate reporting.
- Familiarity with GLP Terminology: Become proficient in key GLP terms, enhancing communication and collaboration with colleagues involved in drug development and compliance.
- Understanding of Historical Context: Explore the evolution of GLP from its inception in the 1970s, learning how historical concerns have shaped current practices and regulations.
Learning Objectives
- Explain what GLP is and where it applies.
- Define a non-clinical study.
- Recognize where non-clinical studies fit into the overall drug approval process.
- Summarize the history of GLP.
- Explain the main terms of GLP.
- Describe the areas GLP covers.
Keywords
- Control Article
- Drug Development Process
- Good Laboratory Practice (GLP)
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Protocol
- Quality Assurance Unit (QAU)
- Raw Data
- Sponsor
- Study Director
- Test Article
Module Features
Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen
