2019 - Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

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