Analytical Method Validation

This course must be taught at a BioNetwork location.

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Level: Beginner
Lecture Hours: 16.00
Lab Hours: 16.00
Total Contact Hours: 32.00


Learn the use of a master validation plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, and the relationship of validation to Good Manufacturing Practices (GMPs). Through case studies and exercises, participants learn the fundamental requirements of preparing a validation protocol, analyzing data, and preparing a final report. FDA inspection expectations are also discussed. The final day of class is a half day.