On Monday 14 November 2011, the FDA presented a webinar entitled "Introduction to the Drug Master File (DMF)". This free of charge webinar discussed all aspects of filing a DMF, including
A recording of this webinar is now available. The presenter, Dr Arthur Shaw, is CDER’s DMF Expert in addition to being a Quality Reviewer in the Office of New Drug Quality Assessment (ONDQA). He has extensive experience in dealing with DMF filing and database issues as well as in reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.
Here you can download the presentation files of the DMF Webinar.