Process Validation in Manufacturing of Pharmaceuticals and Biopharmaceuticals

Venue: Richmond Hill

Location: Richmond Hill, Ontario, Canada

Event Date/Time: Jun 01, 2011 End Date/Time: Jun 02, 2011
Registration Date: May 18, 2011
Early Registration Date: Jun 01, 2011
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Description

Preliminary Program Outline:

Current Regulatory Guidance on Process validation (New Guidelines)
Implementation of Rational QbD Approaches in a Strategy for Biologics Process Validation
How To Perform Process Validation
The key qualification steps in process validation
Quality Risk Management Tools for Process Validation - Applications of Failure Modes and Effects Analysis (FMEA) to Biotechnology Manufacturing Processes
How to apply the latest thinking in process modeling to your process using a Quality by Design approach
Optimize Testing for Validation — What Are the Options?
Validation Process Strategies from Master Plans to Protocols
And more..

Venue

420 Highway #7 East, Box 82022
Ontario
Canada
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