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This three- course series examines essential topics within a quality system--Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The GxP Bundle details the areas covered by each set of requirements and compares US and international regulations. The topics provide the foundation for product quality--critical knowledge for new professionals in regulatory, quality assurance, compliance or related departments such as laboratory management or clinical operations.
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Courses included in this bundle:
Good Clinical Practice
Explore the regulations for conducting research with human subjects. This course explains the role of the informed consent process in protecting human subjects and describes the roles and responsibilities of the clinical review team. It explains how GCPs were developed and cooperation efforts between the US Food and Drug Administration (FDA) and other regulatory agencies.
2–4 Hours | 2 RAC credits
Good Laboratory Practice
Gain an understanding of how GLPs fit into a quality system, what types of studies are covered and how US and international GLPs fit together. This course outlines the reasons for GLPs and describes GLP components. It also compares the GLP regulations under FDA, US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD).
3–6 Hours | 3 RAC credits
Good Manufacturing Practice
Review current Good Manufacturing Practice (CGMP) regulations for the US and EU and their impact on product quality and patient safety. The course addresses reasons for making quality products, areas covered by CGMPs, how pharmaceutical companies ensure compliance, and the consequences for failing to comply with the regulations.
4–8 Hours | 4 RAC credits