Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

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.

Detailed Agenda of the Session:

• What are DMFs?
• Types of DMFs (Types II, III, IV and V)
• The rationale and preparation process for DMFs.
• Why DMFs are important to you and your company
• How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
• Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
• What not to include
• Linkage of DMFs to Quality Agreements
• DMF Preparation: What you need and why you need it.
• The essential components of all DMFs, including:
• The relationship between DMFs and cGMPs
• Tactics for avoiding the most common DMF-related errors
• Tactics for dealing with unique or novel situations/unfavorable reviews
• FDA Review: How FDA reviews DMFs and why.
• What you should expect throughout the DMF preparation and filing process
• How to communicate and work with FDA to ensure success
• Components Associated with a DMF:
• DMF vs. Application
• Acknowledgement Letter
• Letter of Authorization
• Changes to a DMF
• Annual updates
• Obligations of a DMF holder
• Transmissions - transmittal letter
• Deficiency letter
• Auditing Vendor
• Inside tips
• Changes to DMF system in last 10 years
• Binder specifications and cover sample
• Japan DMFs
• European DMFs
• Canadian DMFs
• Change control and maintenance: Why accurately maintaining your DMFs is important.
• DMFs as "living" documents. DMF updates and amendments
• Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
• What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

Learning Objectives:

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 , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Who Will Benefit:

This course is 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:

• Manufacturing
• Regulatory Affairs
• Research and Development
• Quality Assurance & Control
• Validation
• Development and Preparation of Submission Materials

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

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