Annual Product Quality Review: US & EU Comparative Analysis

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Event Date/Time: Feb 04, 2011 End Date/Time: Feb 04, 2011
Registration Date: Feb 04, 2011
Early Registration Date: Feb 04, 2011
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Description

Annual reviews of product data are a GMP requirement of both FDA and EMA. They are a vital element in a Quality Management System and a tool for bringing continuous improvement to products and processes. Failure to produce good and timely reviews has been cited as a major GMP deficiency during regulatory inspections.
This webinar will show how quality reviews:

Drive efficiency and quality improvements
Increase throughput
Reduce batch failures
Reduce product complaints
Improve communication between production, engineering, quality and regulatory functions
Contribute to an ICH Q10-compliant Quality Management System
Topics covered will include:

Overall purpose of annual reviews
Role of annual reviews in a Quality Management System
Comparison of FDA and EMA data requirements
Examples of process improvements driven by annual reviews
Annual reviews and CAPA
How should production, engineering, quality and regulatory contribute to annual reviews?
Contract manufacture and annual reviews

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