Development of Effective Control Strategies Using Product Quality Risk Assessment

Risk management, overlaid on a foundation of sound process and product understanding, is key to effective control strategy development. At Amgen, we have applied Quality by Design principles to improve our risk assessment tools. This presentation will review the Product Quality Risk Assessment (PQRA), and how it is being used to help guide development and maintenance of effective control strategies. The use of the PQRA throughout the product lifecycle will be discussed, along with the benefits realized by project teams.