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.
The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities 2018 covers topics such as:
- 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
The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities 2018 brings together 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
