Drug Master Files - Understanding and Meeting your Global Regulatory and Processing Responsibilities

July 18, 2011 - PRLog -- 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.

# # #

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.