This webinar focuses on how to establish this systematic approach to process development that is defined by Juran's Quality-by-Design (QbD) principles using design of experiments (DOE). Specifically, this webinar demonstrates the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in (pharmaceutical) regulatory guidance documents. Although the webinar uses pharmaceutical development examples, the principles can be applied within any industry.
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Additional biographical information about Heath: Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine 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 to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately 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. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of OR and statistics. Additionally, he taught Operations Research and simulation modeling at the Colorado School of Mines and designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.
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