Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation is a webinar that provides knowledge on how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation covers topics such as:
- Calculation of Sample Size to be taken from each Lot in the Validation study
- Introduction: Regulatory requirements, Basic concepts and vocabulary
- Calculation of % confidence and %Reliability for the Production Process
- Calculation of % Confidence and %Reliability ( = %-in-specification) for each Lot
- Example summary "justification" statement
- Worked example (with all calculations)
- Access to instructor’s website, for downloading free relevant statistical software
Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation is intended for attendees from:
- Quality Assurance Departments
- Research and Development Departments
- Manufacturing Departments
- Quality Control Departments
- Engineering Departments
