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
The course will be especially useful for personnel responsible for:
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Materials
- General Management
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.