1. Presented By J. Richard Creekmore US Technology Manager AstraZeneca Pharmaceuticals Process Robustness: Development to Life Cycle Management

2. Tolerance Limits Understanding of tolerances comes from experimentation (DOE) and experience. Best to have ranges for as many variables as possible, but not practical. Decide which ones are more important (QRA) Some cannot be determined because no method can determine the difference. Only downstream processing and testing might work, e.g. blend uniformity of a non-flowing mixture.

3. Operating Ranges Δ Zone Proven acceptable range or design space may not fill the operating range completely

4. Process Robustness: From Development to Life Cycle Management October 10, 2013 11:15am - 12:15pm Richard Creekmore, US Technology Manager, AstraZeneca Pharmaceuticals Track: Manufacturing & Operations Level: Beginner To register for the INTERPHEX Puerto Rico Educational Program, please visit: www.interphexpuertorico.com/en/Register-Now/ October 10-11, 2013 | Puerto Rico Convention Center | San Juan, Puerto Rico