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.
Why you should attend: The course offers methodologies and techniques on:
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
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 (cGMPs).
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 inspectional trends.
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
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
Who will benefit:
This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:
Global Supply Chain
Research and Development
Quality Assurance & Control
Development and Preparation of Submission Materials