6-Hour Virtual Seminar on Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing

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