Articles by George R. Bandurek, PhD - BioPharm International

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Articles by George R. Bandurek, PhD

Cumulative Sum Charts for Problem Solving

A retrospective analysis for problem solving using cumulative sum charts.
May 1, 2008

CUSUM charts are easy to create in Excel and can reveal when a change occurred.

Using Design of Experiments in Validation

This approach can produce better results for less work than traditional validation methods.
May 1, 2005

Saturated fractional factorial plans minimize the number of trials by one-half or better, which saves time and money.

Making Design Validation Effective

Mar 1, 2005

The purpose of design validation is to demonstrate that a product performs as intended. The usual route to this goal is showing that every item on the specification has been achieved, but it is not an easy path. The specification itself can create difficulty if it includes statements like "as long as possible" or the real horror "to be decided." Verification tests can reveal so many problems that the design must change to such an extent that earlier tests are no longer relevant. And there is also the practical difficulty of obtaining sufficient samples to test when the manufacturing engineers have not completed their standard operating procedures, the product design is not fixed yet, the component suppliers are late, and the marketing department has taken all the samples to show to prospective customers.

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