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Date: 27th - 28th July, 2009

Location: Costa Mesa, CA, USA

Summary:
Pharmaceutical - Training

This course provides comprehensive and up-to-date knowledge of analytical method validation for quality assurance and control of pharmaceutical and biopharmaceutical products; bioanalytical method validation is also covered briefly. The course covers regulatory expectations regarding analytical method validation as contained in U.S. and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant method validation plans, and to prepare for regulatory audits. There will be discussion of real-life situations regarding non-compliant practices found during regulatory audits, and the opportunity to discuss specific analytical method validation issues raised by attendees in a roundtable format.

Analytical Method Validation for Quality Assurance of Pharmaceutical Products