Introduction to the Drug Master File (DMF) Webinar - November 14, 2011

On Monday, November 14, 2011 at 11:00 a.m. (ET), our CDER Small Business Assistance Program will present our webinar entitled Introduction to the Drug Master File (DMF) which will discuss all aspects of filing a DMF, including when and why to submit a DMF; requirements and recommendations for formatting and submitting original DMFs and subsequent submissions; how DMFs are reviewed and common problems.

Our presenter will be Dr. Arthur Shaw who 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 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.

Dr. Shaw’s previous positions in FDA include Special Assistant in the Office of New Drug Chemistry and Review Chemist in the Division of Gastrointestinal and Coagulation Drug Products and in the Division of Pulmonary and Allergy Drug Products. Dr. Shaw received a B.S. in chemistry (with Honors) from the City College of New York and a Ph.D. in biochemistry at Cornell University.

  

Registration website: https://collaboration.fda.gov/dmf/event/registration.html

Web Address for viewing on day of event: https://collaboration.fda.gov/dmf/event/login.html

Call in numbers (listen only mode): 

Domestic: 1-800-857-0171

International: 1-517-319-9290     

Password (verbal): 2718839

For More Information: 

http://www.fda.gov/smallbusinessdrugs

Click on Workshops and Webinars in Spotlight box

Webinar by CDER, FDA

CDER's Small Business Assistance Program introduces a new webinar, "Import of Human Drugs and Human Drug Components" which will focus on the compliance perspective of FDA’s import regulations on human drugs and human drug components. The discussion will include topics such as detention, refusal of admission, Transportation and Exportation (T&E) and Foreign Trade Zones (FTZ).


This presentation will be given by Bill Nychis, Senior Compliance Officer in the Import Operations Branch (IOB), Division of Import Operations and Recalls, Office of Drug Security, Integrity and Recalls, within the CDER Office of Compliance.

When: Thursday June 16, 2011, 11:00 AM (EDT)

It is recommended that you register and obtain your password prior to the day of the event. You can register at: Import of Human Drugs and Human Drug Products Webinar
For more information and past webinars, please visit us at: FDA Small Business Assistance: Workshops and Webinars