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According to 21 CFR, Part 820, medical device manufacturers are required to validate as well as monitor and control parameters for their processes. The guideline on Quality Management Systems does not specify how this is accomplished; only that “a process is established that can consistently conform to requirements” and “studies are conducted demonstrating” this. Thorough process development, optimization and control using appropriate statistical methods and tools is recommended for demonstrating that your process is both stable and capable. This session will demonstrate ways to efficiently and effectively apply recommended statistical methods and tools to process validation—with no statistical expertise needed. Using realistic process data, participants will learn how to apply tools, interpret results and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).