Drug Master Files (DMF) - Translating FDA Guidances into usable documentation 2019 will be held in San Diego, CA, United States on 18-19 July 2019.
Drug Master Files (DMF) - Translating FDA Guidances into usable documentation 2019 is a seminar that covers topics such as:
Five types of DMFs and their uses
Two FDA websites and three FDA guidance documents regarding DMFs
21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files
Drug Master Files (DMFs)
Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances
Drug Master Files: Guidelines
Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
When the DMF should be filed with the FDA
Information to be contained in the DMF
Checklist to construct a DMF from scratch
Experiences of others regarding real world issues associated with creating and submitting DMFs
Drug Master Files (DMF) - Translating FDA Guidances into usable documentation 2019 brings together attendees from Regulatory Affairs, Manufacturing, Quality Assurance & Control, Research and Development, Development and Preparation of Submission Materials and Validation.