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

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities 2019 is an event dedicated to current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed.

Topics

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

Who should Attend

Attendees from:

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