Webinar

Data-Driven Risk Management: a Practical Approach to Minimize Subjectivity

Margarida Ventura

Author

Margarida Ventura

Senior Consultant in Delivery

ValGenesis

LinkedIn

Published on August 3, 2023

Part of: CMC Development

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. 

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