(424a) A Quality Systems Approach to the Product Quality Risk Management Lifecycle

As the knowledge base is built during development many of the risks to product quality and patient safety are identified and linked to inputs involving raw materials, equipment and facility design and processes. A comprehensive understanding about how all of these variables influence one another and interact allows manufacturers to implement sophisticated process control strategies and technologies that minimize process and product variability. A sound approach to quality risk management also utilizes the knowledge and experience gained after commercialization from monitoring of product quality and process performance. High quality products and reliable processes are maintained throughout the product lifecycle via the quality system infrastructure which collects and manages new information and relates it to the existing knowledge base. This presentation will discuss how quality risk management continues beyond product development, showing the vital role an effective quality system plays in maximizing the effectiveness of risk management in making continual improvements throughout the product lifecycle. ‬‪