Regulatory: what is GMP?
Course
About course
This free online course provides a high-level overview of the good manufacturing practice (GMP) area of the chemistry, manufacturing, and controls (CMC) section of the common technical document (CTD). When you are seeking approval to trial a new drug in humans, completing the CTD can be tricky. This course will help you to:
- Understand the regulatory process of GMP in terms of CMC
- Explain why and when it is necessary
- Determine if you should perform GMP-compliant manufacturing in-house or outsource it
After diving into the details, you’ll review a case study from an expert on the topic as well as find links to supporting resources. If you come across unfamiliar terms, check out the glossary of some key regulatory terms, processes, acronyms, and their definitions.
You can access and complete each lesson individually, with the full course taking around 20 minutes to complete.
Certification
You will get an online certificate after the course completion. You can view and download it in a section My Courses. With Cytiva Certificates, portions of our programs have been split into online modules, so you can earn a high quality knowledge in interactive format.
