GxP Industry Overview
This course provides an introduction to the drug development pipeline; the regulatory authorities that oversee the drug development process; and the standards that have been developed to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. It also describes the process of identifying, developing, and testing new drugs, and the regulatory authorities that oversee the process. In addition, it discusses the standards maintained by regulatory authorities to guide laboratory testing, clinical trials, and drug manufacturing.
After completing this course, participants should be able to:
- Describe the steps of the drug development process
- Identify the regulatory authorities in the US, Europe, Canada, and Japan that oversee the drug development process
- Discuss the responsibilities of the regulatory authorities in protecting public health
- Discuss the differences and similarities between the EMEA, the FDA, the MHLW, and the HPFB
- Provide the historical context behind the formation of regulatory agencies
- Define GMP, cGMP, GLP, and GCP
- Discuss the history and purpose of the GxP standards
- Discuss recent developments in international standardization of regulatory guidelines
- Describe the importance of the GxP standards in protecting public health
- Quickly access important documentation and links to FDA and EMEA regulations
Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.