Basic Concepts of Validation
Describes the use of a master validation plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, and the relationship of validation to the Good Manufacturing Practices (GMPs). Through case studies and exercises, participants will learn the fundamental requirements on how to prepare a validation protocol, analyze data, and prepare a final report. Also covered, US Food and Drug Administration's (FDA) inspection expectations for qualification and validation of facilities, equipment, and processes.
Primary Audience: Industry
Secondary Audience:
Primary Industry Sector:
Secondary Industry Sector: na
Program Type: Continuing Education
Lecture Hours:
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