Description
In this Good Laboratory Practice (GLP) compliance training course, we will delve into the history, regulatory agencies, and fundamental principles of GLP. Whether you are a scientist, researcher, member of the QA or QC staff, or a laboratory technician, this course will help to equip you with the knowledge and awareness necessary to ensure compliance with GLP regulations.
The course provides an introduction to GLP, its importance, historical context, and evolution. The introduction section will also describe who the key stakeholders in GLP compliance are.
In section two, GLP regulatory agencies are introduced, such as the FDA’s 21 CFR Part 58, European Medicines Agency (EMA), Medicines & Healthcare Products Regulatory Agency (MHRA), Organisation for Economic Co-operation and Development (OECD), and World Health Organization (WHO).
The course moves on to describe the principles of GLP, and as it applies to organization and personnel, study director & QA department, facilities and equipment, test and control articles, labeling, and standard operating procedures (SOPs).
This course provides emphasis on the importance of documentation and data integrity, and as they apply to accurate record-keeping, lab notebooks and logbooks, and electronic data handling and compliance.
The quality control and quality assurance groups responsibilities are described, as well as how to implement quality control measures and quality assurance in GLP studies. Handling deviations and non-compliance are additionally described.
Lastly, safety and environmental considerations are introduced as well as some case studies resulting in FDA warning letters.
Good Laboratory Practice (GLP) is vital in research and development due to its role in ensuring data integrity, regulatory compliance, safety, and the overall quality of laboratory studies. Adherence to GLP standards is not only a regulatory requirement but also a best practice that fosters trust, reliability, and progress in scientific research and product development.
