Published on October 1, 2024

Part of:

In this webinar, we will explain how ICH Q9 (R1) introduced the need to manage and minimize subjectivity in risk management to enhance scientific sound risk-based decision making. In this presentation, a practical approach to respond to this need is outlined in the context of production process risk management. A set of digital state-of-the-art integrated tools is used to manage risk assessment activities. Once a risk baseline is defined, based on an existing set of tacit and explicit knowledge (if available), an iterative process of risk refinement is defined in which risks are re-calculated as new data and knowledge is available. Besides RPN revision, the integration with data allows the identification of new risks for a continuously improved control strategy. 
03 Aug