Name: The Use of Drug Master Files & Quality Agreements 2021
Start: Fri, 11/05/2021 - 11:00
End: Fri, 11/05/2021 - 05:00
Location: Online

Event Description

The Use of Drug Master Files & Quality Agreements 2021

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.

Learning Objectives:

The course offers methodologies and techniques on:
Quality Agreements

The Origin and Background around Quality Agreements
When are Quality agreements appropriate?
The Scope of Quality Agreements
Quality Agreement Formatting and Content
How to negotiate a Quality agreement

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).

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: