Who Should Attend
This course was developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:
- Regulatory Affairs
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Materials
In addition, anyone involved in areas of production or validation will find this course useful.
The course will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.
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.
This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The 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