辉瑞企业培训资料（英）.pptVIP

Managing Pharmaceutical Quality: Risk or Uncertainty Management? ;What is Quality?;Management Goals;An Approach for Quality – Risk Connection;A Systems Approach;Quality can not be tested into a product; it has to be by design;Risk/Benefit and Quality;Managing Pharmaceutical Quality;Managing Pharmaceutical Quality;Uncertainty, Variability and Risk;Goals and Characteristics of a Quality Decision System: Example ;ANDA Applications: Limited Information Content (e.g., IR Capsule);Demonstration of “quality by design”?;Uncertainty, Variability and Risk;Uncertainty, Variability and Risk;Example of a C