|Risk-based Engineering Assessment and Qualification: A Case Study|
|Presented at the WBF North American Conference, March 5–8, 2006, by|
|Chinmoy RoySenior Automation Engineercroy@gene.comGenentech Inc., 1 DNA Way, MS 252A,South San Francisco, CA 94080 USA|
|Tom JohannessenAutomation System Administratorhemnes@gene.comGenentech Inc., 1000 New HorizonsWay, Vacaville, CA 95688 USA|
A recent spate of life-saving drug discoveries is requiring drug manufacturers to bring these drugs to market faster, at a lower cost. These challenges need to be met while maintaining a high level of drug manufacturing safety. Besides the challenge of reduced time to market, there is also an increasing realization that drug costs can be lowered ...