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
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.
Lunch 
AM-PM Tea/Coffee 
Seminar Material 
USB with seminar presentation 
Hard copy of presentation 
Attendance Certificate 
$100 Gift Cert for next seminar 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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