This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
Upon completion of this course, attendees will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.
Who Will Benefit:
This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:
- Regulatory Affairs
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Materials
Note: Use this promocode(117660) for 10% discount.