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.

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

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