OVERVIEW

Drug Master Files (DMF's) - Understanding And Meeting Your Regulatory And Processing Responsibilities is organized by GCPlearning.

Who Will Benefit:
The course is addressed to personnel in the areas of the company involved in the preparation of regulatory documentation personnel from Regulatory Affairs, Quality Assurance, Quality Control, R&D, and, in general, all personnel with responsibilities in the preparation and maintenance of formal documentation of products. The course will be especially useful for personnel responsible for:

• Managers, technical staff for QA and QC, and regulatory affair personnel for API companies
• Technical staff for QA and QC, and regulatory affair personnel for packaging material, excipient, colorant, and flavor essence companies

Overview:
This course provides attendees with a basic understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics.

The course will overview the process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course will explain the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.
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.

Areas Covered in the Session: