Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
31 March 2010 - 01 April 2010
Presented by: The Center for Professional Innovation & Education   -   Location: Malvern, PA USA
Contact: Michael Roberts  info@cfpie.com -  610-688-1708    http://www.cfpie.com/showitem.aspx?productid=026&source=gxp

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Upon completion of this course, attendees will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs and present strategies for establishing and maintaining effective change control programs and facilitating communications with regulatory agencies and your own customers and vendors.