World Conference Calendar

32801 Conferences

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - Pharmaceutical Webinar By ComplianceOnline

Added by Referral on 2010-11-18

Conference Dates:

Start Date Start Date: 2011-01-12
Last Date Last Day: 2011-01-12

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

Why Should You Attend:

This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFs course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

The course offers methodologies and techniques on:

Who really needs a DMF and why?
The various types of DMFs - which is best for your products.
The relationship between DMFs and drug and biologics applications.
The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
Common DMF errors - how to avoid them.
How to deal with deficiency letters and their origins.
Effective change control strategies.
Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.
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