Statistical Quality Control in Pharmaceutical and (IVD Industries)

Overview: Process validation is the establishment of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality characteristics. Areas Covered in the Session: The first step in establishing the control chart is to set the QC limits. The formula "Mean +/- 3*SD" is often taken for granted, the webinar will explain how the QC limits should be established. Why Mean? Why 3? Why SD? Why are the upper and lower limits symmetric around the mean? What N should be required to do this calculation.