Statistical Justification for Sample Size and the Use of Only 3 Lots for Process Validation

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.

Topics

• 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

Who should Attend

Attendees from:

• Quality Assurance Departments
• Research and Development Departments
• Manufacturing Departments
• Quality Control Departments
• Engineering Departments