Online Program Home
  My Program

Abstract Details

Activity Number: 566 - Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals
Type: Topic Contributed
Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
Sponsor: Section on Risk Analysis
Abstract #322902 View Presentation
Title: Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals
Author(s): Lynne Hare*
Companies: Statistical Strategies, LLC
Keywords: Design of Experiments ; Control Charts ; Acceptance Sampling
Abstract:

Opportunities for improving the application of statistical methods for process validation in the areas of design of experiments (DOE), control charting and acceptance sampling are presented. While each of these areas is taught in various internal and external programs, their applications often fall short of the original intent. DOE often falls prey to those who would play the winner. Control charting is carried out incorrectly resulting in its being ignored, and acceptance sampling plans are selected from a catalog instead of being tailored to the application. Danger areas are pointed out, with examples.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2017 program

 
 
Copyright © American Statistical Association