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Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities

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Description and objective: This course provides a background and understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. It will take you step-by-step through the DMF preparation process and explain the types of information that are essential for any DMF. It also explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for your 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

The course consists of lectures, small group discussions, and a practical workshop, which will enable participants to draft a drug master file outline for their respective companies' needs.

Contact The Center for Professional Innovation & Education

Phone	1-610-688-1708 When calling be sure to mention Training Pages
Fax	1-610-688-7817

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Categories

•	Industry Specific Skills > Pharmaceutical and Biotechnology > Biotechnology
•	Industry Specific Skills > Pharmaceutical and Biotechnology > Pharma and Bio Project Management