Guidelines in Good Clinical Laboratory Practice
Guidelines in Good Clinical Laboratory Practice
Guidelines in Good Clinical Laboratory Practice
Industry Specific
This course will review Good Clinical Laboratory Practice (GCLP) standards that embrace both the research and clinical aspects of GLP utilizing a variety of collected regulatory and guidance material. We will cover eleven core elements that constitute the GCLP standards with the objective of filing ta gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. Other topics include performance of protocol-mandated safety assays, peripheral blood monocular cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials, safety training, quality management program, quality assurance, and reporting.
COURSE INFORMATION
N/A 15 minValid for 24 monthsCreated 2017-05-30Updated 2017-05-30
Course Objectives
- Review the GCLP standards that embrace both research and clinical aspects.
- Describe 11 core elements that constitute the GCLP standards.
- Understand GCLP standards on providing guidance on implementing requirements crucial to laboratory operations.
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