Statistics for Process Validation – Medical Device
Date: June 21, 2021
Time: 10:00 – 11:00 PM Eastern
Instructor: Heath Rushing
Register by email firstname.lastname@example.org
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 are recommended for demonstrating your process is both stable and capable.
This webinar will focus on teaching how to efficiently and effectively apply recommended statistical methods and tools to process validation. This webinar focuses on how to apply these tools, interpret results, and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Be able to use both risk management tools (cause-and-effect diagram and FMEA) and design of experiments (DOE) during process development as well as validation/qualification
- Be able to generate and interpret process control charts and capability indices for process validation/qualification as well as production startup
- Understand the need to establish, implement, and maintain a control plan