6-Hour Virtual Seminar on Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing
September 14, 2021 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: The Virtual 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 6 hours 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 recommendations