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Vital QMS Process Validation Statistics

BEST PRACTICES SESSION ROOM  | Wednesday, June 13 | 10:00 am - 11:00 am
Speaker: Heath Rushing, Co-Founder, Adsurgo, LLC



    While all attendees will benefit from this session, the check marks indicate the skill level and roles that this session targets.
    Beginner  |   Intermediate  |  Advanced

  √ Manufacturing
Product Management
 √ Quality Control
√ Regulatory/Clinical Affairs
√ Research/Development/Design
 Supply Chain Management



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).

Attendee Takeaways

  1. Guidance on the need for statistical methods in process validation
  2. The application of hypothesis testing, data intervals, measurement systems analysis and sample size calculations during Installation Qualification (IQ)
  3. The application of risk management tools, design of experiments and process control/capability during Operational Qualification (OQ)
  4. The application of risk management tools and process control/capability during Performance Qualification (PQ)





Rushing2 200x200Heath Rushing is Co-Founder of Adsurgo, LLC and an international speaker on applicability of statistics. Previously, he was the JMP and Six Sigma training manager at SAS, where he led a team of technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications and long-term training plans in quality and statistics across a variety of industries including biotech, pharmaceutical, medical device and chemical processing. As a Quality Engineer at Amgen, Rushing championed statistical principles in every business unit. He created and delivered a design of experiments (DOE) course that became the company standard, required at multiple sites. Additionally, he developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability and validation acceptance criteria. Mr. Rushing is co-author of the book, Design and Analysis of Experiments by Douglas Montgomery: A Supplement for Using JMP.