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)