The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities 2018 is a seminar dedicated to the advantages for suppliers and drug product manufacturers in developing DMF (Drug Master Files) and Quality Agreement together.
Topics
- The use of DMFs in the EU, Japan, Canada and Australia
- Review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel
- How to prepare Quality Agreements, Drug Master Files (DMFs) with the FDA and the rationale behind doing so
- Similarities and differences to the U.S. system
- 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
- 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 movement by U.S. FDA to convert from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments
Who should Attend
Attendees involved in the manufacture of Pharmaceutical, Biologic and Medical Device products, components, and packaging materials with responsibilities in:
- Regulatory Affairs
- Manufacturing
- Global Supply Chain
- Project Managers
- Quality Assurance & Control
- Research and Development
- Development and Preparation of Submission Materials
- Validation
- General Management
