Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

Overview:This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers 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 lies 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.

Areas Covered In 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
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

Who Will Benefit:
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
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products. For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries. He holds a BS / MS in Chemistry.”
Event link:
https://www.compliance4all.com/webinar/-502916LIVE?channel=fortcollinschamber_2020_SEO
Contact Info
Netzealous LLC, DBA -Compliance4all
Email: [email protected]
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/