Course Description:

Course "Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation" has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.

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  • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research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    • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.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     Day Two
  • 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 (60 Min)
  • 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 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

Joy Frestedt, PhD, CCTI, RAC, FRAPS
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.

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The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation" RAPS certificate will be issued to attendee.

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