In this Drug Master Files (DMF's) training learn how and why the DMF's is submitted to FDA and how it intended to be used.
Why Should You Attend:
A Drug Master File is a submission of information to FDA by a person or organization who intends it to be used by others for one of several different purposes. To facilitate this use, FDA has defined five types of drug master files each of which has been defined for a specific purpose. The file may contain information of the kind required for the submission to the agency. This program will explain in detail what a drug master file entails, how and why it is submitted to FDA, and how it is intended to be used. It is important to understand that a DMF is not a substitute for and IND, NDA, ANDA or Export Application. It is intended to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file.
Areas Covered in the Seminar:
- Introduction.
- Definitions.
- Types of Drug Master Files.
- Submissions to Drug Master Fines.
- Drug Master File Contents.
- Format, Assembly and Delivery.
- Authorization ro Refer to a DMF.
- Processing and Reviewing Policies.
- DMF Holder Obligations.
- Transfer of Ownership.
- Closure of a DMF.
Who Will Benefit:
- Regulatory affairs managers & directors for pharma manufacturers and their suppliers
- Manufacturing
- Research and Development
- Quality Assurance & Control
- Validation
- Development and Preparation of Submission Materials
Instructor Profile:
James R. Harris, has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. He has advised manufacturers around the globe about DMFs and has aided in the creation of many such documents.
