Overview

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

The course will include 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, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

The conversion of paper to e-filings requirements with FDA will also be discussed. The process used for e-filings will be reviewed in detail. Maintaining filings for Annual Reports and DMF Amendments will also be covered.

Upon completion of this course, attendees will understand how to prepare Quality Agreements, Drug Master Files (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 the strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs, present strategies for establishing and maintaining effective change control programs, along with facilitating effective communications with regulatory agencies along with customers and vendors.

The course will also discuss the movement by U.S. FDA to convert from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments.

Why you should attend

This course provides attendees with an understanding of the role that Quality Agreements and 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 when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement.

The DMF section will explain content, format, preparation and the types of  Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. 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.

Areas Covered in the Session

DMFs

• 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 (c-GMPs)
• 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 inspection trends
• The conversion from paper to e-filings at FDA for Human and Veterinary Products

Who Will Benefit

This course is developed for those involved in the manufacture of Pharmaceutical, Biologic and Medical Device  Products, Components, and Packaging Materials. The course will be especially useful for personnel responsible for:

• Manufacturing
• Regulatory Affairs
• Project Managers
• Global Supply Chain
• Research and Development
• Quality Assurance & Control
• Validation
• Development and Preparation of Submission Materials
• General Management

Speaker Profile