Drug Master Files (DMF) - Translating FDA Guidances into usable documentation 2019

Key Topics

• 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  • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research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

Who should Attend

Attendees from Regulatory Affairs, Manufacturing, Quality Assurance & Control, Research and Development, Development and Preparation of Submission Materials and Validation.