GXP: Industry Overview
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Download Sunday, May 24, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:INTRODUCTION 1. Course Information 2. Interface Tour 3. Course Overview PIPELINE AND PLAYERS 4. Objectives 5. The Drug Pipeline 6. Regulatory Overview 7. The FDA 8. EMEA 9. Japan 10. Canada 11. Progress Check GxP REGULATIONS 12. Objectives 13. GMP 14. cGMP 15. GLP 16. GCP 17. Progress Check CONCLUSION 18. Summary | Objectives:Describe the steps of the drug development process. Identify the regulatory authorities in the U.S., 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. | |
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