Introduction to GXPs
BIOL-40353
The pharmaceutical industry is tightly regulated, allowing the commercial sale of medicinal products only if regulatory requirements are met. This course emphasizes the US FDA GXPs that apply to managing quality within the pharmaceutical, chemical, and biotechnology industries and touches on differences between the other regional markets in the rest of the world. Students will gain an introduction to Good Practices (or GxPs) including Manufacturing (GMPs), Clinical (GCPs), Laboratory (GLPs), and Automated Manufacturing (GAMPs), and will explore the lifecycle of a drug, from development through to commercial production.
Course Information
Course sessions
Section ID:
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
All course materials are included unless otherwise stated.
Policies:
- No refunds after: 1/13/2025
