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Pharmaceuticals 2012 - Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
Date2012-03-30
Deadline2012-03-30
VenuePalo Alto, USA - United States 
KeywordsPharmaceutical Quality Agreements; Biologic Quality Agreements; Drug Master Files; Technical Files; DMFs in the EU; DMFs in the US; Japan DMFs; Canadian DMFs; Change Control for DMFs
Topics/Call fo Papers
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Why Should You 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.
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:
- Manufacturing
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Validation
- Development and Preparation of Submission Materials
- General Management
Why Should You 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.
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:
- Manufacturing
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Validation
- Development and Preparation of Submission Materials
- General Management
Other CFPs
- US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
- Dietary Supplements: Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
- Dietary Supplements: Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
- New Dietary Ingredients in the Regulatory Scheme
- Validation of Bioanalytical Assays for Biologicals
Last modified: 2011-11-14 21:08:03