Drug Master Files (DMF) - Translating FDA Guidances into usable documentation


Drug Master Files (DMF) - Translating FDA Guidances into usable documentation 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    • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research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 brings together attendees from Regulatory Affairs, Manufacturing, Quality Assurance & Control, Research and Development, Development and Preparation of Submission Materials and Validation.

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