Overview:
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.
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:
DMFs
- 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:
This 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
responsible for:
- Manufacturing
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Validation
- Development and Preparation of Submission Materials
- General Management