This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in 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 lie 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.
The course will include the current review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
The conversion of paper to e-filings requirements with FDA will also be discussed. The process used for e-filings will be reviewed in detail. Maintaining filings for Annual Reports and DMF Amendments will also be covered.
Upon completion of this course, attendees will understand how to prepare Quality Agreements, Drug Master Files (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 the 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 along with customers and vendors.
The course will also discuss the movement by U.S. FDA to convert from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments.
Why you should attend
This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement.
The DMF section will explain content, format, preparation and the types of Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. 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.
Areas Covered in the Session
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 (c-GMPs)
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 inspection trends
The conversion from paper to e-filings at FDA for Human and Veterinary Products
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Materials
- General Management
The Origin and Background around Quality Agreements
When are Quality agreements appropriate?
The Scope of Quality Agreements
Quality Agreement Formatting and Content
How to negotiate a Quality agreement
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 c-GMPs
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
Letter of Authorization
Changes to a DMF
Obligations of a DMF holder
Transmissions - transmittal letter
Changes to DMF system in last 10 years
Binder specifications and cover sample
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
• Regulatory Affairs
• Project Managers
• Global Supply Chain
• Research and Development
• Quality Assurance & Control
• Development and Preparation of Submission Materials
• General Management