526001 Design and Implementation of a Control Strategy Using Risk-Based Probabilistic Design Principles: A Case Study in the Manufacturing an API with a Critical Impurity

Federico Lora Gonzalez1, Jose E. Tabora2, Eric C. Huang2, Steven R. Wisniewski2, Thomas M. Razler1 and Brendan C. Mack2, (1)Bristol Myers Squibb, New Brunswick, NJ, (2)Bristol-Myers Squibb, New Brunswick, NJ