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Date: 12th - 14th May, 2008

Location: Toronto, Canada

Summary:
Pharmaceutical - Training, Seminar

An Important Three Day Comprehensive & Interactive Workshop Series with Discussions and Case Studies on:

- Change Control System Criteria and Requirements
- Regulatory Considerations for Change Control
- Review of Recent 483s and Warning Letters
- Creating a Harmonized Global Change Management System
- Management and Risk Assessment: ICH Q9 Risk Management
- Changes During Product Development
- Closing Out a Change Control
- Post Change Monitoring Requirements and Strategies
- Conducting Gap Analysis of a Change Control Process
- Change Control in the Laboratory
- Change Control in Manufacturing and Packaging Facilities
- Change Control and Validation
- Automation of Change Control Processes
- Change Control System Documentation, Procedures and Forms
- Creating Change Proposals and Completing a Change Request
- Change Control Metrics