2019 - Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

Introduction
Regulatory requirements
Basic concepts and vocabulary
Calculation of Sample Size to be taken from each Lot in the Validation study
Calculation of % Confidence and %Reliability ( = %-in-specification) for each Lot
Calculation of % confidence and %Reliability for the Production Process
Worked example (with all calculations)
Example summary "justification" statement
Access to instructor's website, for downloading free relevant statistical software