Drug Master File (DMF) Preparation and Maintenance – A Regulatory Perspective

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Sep 25, 2008 End Date/Time: Sep 26, 2008
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Description

Effective DMF Establishment and Management Strategies

A Two Day COMPREHENSIVE & INTERACTIVE Course with Presentations and Discussions on:

- Role of DMFs in the regulatory approval process for drugs and biologics
- Procedures and Strategies for Efficient DMF preparation
- Complying with current DMF guidance
- How FDA reviews DMFs
- EU and US efforts to harmonize DMF systems
- Review and Comparison of DMF Types II, III, IV, V
- Meeting Content Requirements for Drug Master Files
- Complying with Chemistry Manufacturing and Controls (CMC) Requirements
- Documentation Management for DMF Preparation
- Customizing the DMF to your specific products, practices and operations
- Maintenance Strategies and Changes to a DMF
- Meeting DMF Holder Obligations and Letters of Authorization (LOA)
- Optimizing DMFs as a communication tool to the agencies

Venue

Toronto
Toronto
Ontario
Canada
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