Statistical Process Control -Verification, Validation, Risk Management, Manufacturing, and QA/QC 2017

Course "Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
•    ISO standards and FDA/MDD regulations regarding the use of statistics.
•    Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
•    Statistical Process Control
•    Statistical methods for Design Verification
•    Statistical methods for Product/Process Qualification
•    Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
•    How to craft "statistically valid conclusion statements" (e.g., for reports)
•    Summary, from a risk management perspective

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