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A History of a cGMP Medical Event Investigation

A History of a cGMP Medical Event Investigation by Michael A. Brown
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MICHAEL A. BROWN, PhD, PE, is a Visiting Professor at the University of Illinois at Chicago. Dr. Brown has twenty-five years' experience in the biomedical industry in a product and process design capacity with responsibilities for worldwide engineering and management. He has served as a lead engineer on numerous products, process, and equipment projects including design, implementation, and qualifications. He is a registered Professional Engineer and a certified Six Sigma Black Belt with considerable experience in team leadership. The material presented in this case, including the FDA regulations and Six Sigma concepts, was tested in an engineering senior design course taught by Dr. Brown over a three-year period. Student feedback noted that the difficult design principles were explained in an easy-to-read story that introduced them to the Six Sigma methodologies in an engaging manner.

Wiley; December 2012
252 pages; ISBN 9781118494882
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Title: A History of a cGMP Medical Event Investigation
Author: Michael A. Brown
 
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