Drug Master Files (DMF) – Translating FDA Guidances into Usable Documentation: One and a Half-day In-person Seminar

By: Robert J. Russell, President and CEO, RJR Consulting, Inc
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Course Description:

The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product.

This course will review two FDA websites and the three FDA guidances pertaining to DMFs

  • Drug Master Files (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: Guidelines
  • Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances
  • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research

Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the course will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation.

Learning Objectives:

  • Understand the two FDA websites and three FDA guidance documents regarding DMFs.
    • Drug Master Files (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: Guidelines.
    • Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances.
    • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.
  • Review the five types of DMFs and their uses.
  • Able to develop the information to be contained in the DMF.
  • Understand when the DMF should be filed with the FDA.
  • Be able to describe experiences of others regarding real world issues associated with creating and submitting DMFs.
  • Able to use a checklist to construct a DMF from scratch.

Who will benefit:

  • Manufacturing
  • Regulatory Affairs
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30-8:59 AM Registration. Meet & Greet.
  • Introductions (15 Min)
    • Instructor
    • Participants
  • Session 1: DMF s (75 min)
    • What is it?
    • Who benefits from them?
    • Relationship to drug and biological applications
    • Definitions
    • 2 FDA website reviews
    • 3 Guidance document overviews
  • Break (30 Min)
  • Session 2: Types of DMF (30 min)
    • Type 1: Manufacturing (retired)
    • Type 2: Drug Substance
    • Type 3: Packaging
    • Type 4: Excipients
    • Type 5: Other
  • Workshop: Defining the type of DMF to submit (90 min)
  • Lunch
  • Session 3: Drug Master File Contents (60 Min)
    • Administrative requirements
    • Technical Requirements
  • Break (30 Min)
  • Session 4: Relationship between DMFs and current Good Manufacturing Practices (cGMPs) (30 min)
  • Case Study: Determining the supporting evidence for a submission (90 Min)
  • Day TWo (8:30 AM – 12:30 PM)
  • Day 1 Recap (15 min)
  • Session 5: FDA Submissions (60 Min)
    • What to include and what not to include
    • Format
    • Essential information
    • Key documents
    • Assembly/ Binder Specifications
    • Delivery
  • Workshop: Creating a checklist (60 min)
  • Break (30 Min)
  • Session 6: Ongoing obligations (30 Min)
    • Changes to DMF
    • Transfer of ownership
    • Closure of a DMF
    • Retirement of DMF
  • Q&A and Conclusions (45 min)
  • Meet Your Instructor

    Robert J. Russell
    Robert J. Russell,
    President and CEO, RJR Consulting, Inc

    Bob is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

    His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products.

    For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.

    He holds a BS / MS in Chemistry.

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