Conducting Quality System Gap Analysis Assessment

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Sep 15, 2008 End Date/Time: Sep 16, 2008
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A Two Day Comprehensive & Interactive Course, with Workshops and Case Studies On:

- Interpreting and Applying ICH Q10 Pharmaceutical Quality Systems Guidance
- Comparing cGMP Requirements versus ICH Q10 Guidance
- Essential elements to successfully transition from cGMP to a Quality System
- Designing and Implementing a Pharmaceutical Quality System
- Managing the Quality System and Supporting Processes
- Using Quality Risk Assessment and Risk Management
- Applying a Systems Approach for Assessment and Measurement
- Conducting a Gap Analysis of Quality Systems
- Developing Effective Quality Policy and Quality Planning
- Making Decisions Based on Understanding the Intended Use of a Product
- Tools and Techniques to Review Current Quality Activities
- Systems for Careful Analysis of Product Quality
- Identifying and Controlling Areas or Weakness in the System or Process
- Deviation and Investigation Management for Effective and Timely Remediation
- Maintaining a Well Defined Process and Product throughout the Product Life Cycle