Regulatory: what are drug master files?
Course
About course
This free interactive course provides a high-level overview of drug master files (DMF) for new drug development. DMFs are submissions to the FDA and other regulatory authorities that provide confidential and detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products without disclosing the contents to others.
Key learnings:
- Understand why DMFs are important and where they are used
- Identify creation and submission resources
- Explain what you need to do when a DMF is changed or closed
After diving into the details, you’ll hear 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.
