Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation  

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Seminar Summary:

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.  (see full course description)

 

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Training Course Syllabus:


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    • Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.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


Seminar Summary:

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.  (see full course description)

print this agenda print agenda for the Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation training seminar

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