This combined DMF (Drug Master Files) and Quality Agreement
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
The course will include the current review and
enforcement climate within FDA and the manner, in which Drug Master
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.
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
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
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.
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
Who Will Benefit
course is developed for those involved in the manufacture of
Pharmaceutical, Biologic and Medical Device Products, Components, and
Packaging Materials. The course will be especially useful for personnel
- 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.
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
Time: 08:00 AM PST | 11:00 AM ESTQuality Agreements
What are DMFs?
- 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
The Rationale and Preparation Process for DMFs
- Types of DMFs (Types II, III, IV and V)
DMF Preparation: What you need and why you need it
- 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
FDA Review: How FDA reviews DMFs and why.
- 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
Components Associated with a DMF:
- What you should expect throughout the DMF preparation and filing process
- How to communicate and work with FDA to ensure success
- 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
Canadian DMFsChange control and maintenance: Why accurately maintaining your DMFs is important
- DMFs as "living" documents. DMF updates and amendments
of DMF-related changes that impact drug/biologic applications:
production facilities, composite materials, manufacturing processes
you must report and to whom - the importance of establishing
communication pathways with regulatory agencies, customers and vendors
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