The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 7, 2015 at 9am to May 8, 2015 at 6pm
Location: Raleigh, NC
Street: Raleigh, NC
Website or Map: https://www.globalcompliancep…
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Feb 24, 2015
This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that will also help improve the product.
All design and/or manufacturing companies perform design verification and/or process validation studies. A solid understanding of relevant statistical concepts and methods ensures that such efforts are efficient and accurate. In addition, all validated processes must be monitored to ensure their continued suitability (per the FDA).
John Zorich has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical.
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