In this presentation, the «Agile/Iterative Method according to GAMP5 2nd Edition» will be further elaborated. We will be engaged with the question on how the development and implementation of AI/ML (artificial intelligence/machine learning) - computer system validation could look like in a regulated environment. Based on a case study, you will to be taken along the journey where the line of thoughts as well as the necessary steps are explained in order to successfully complete such an intend. Furthermore, we will dive more specifically into the approach and make a direct comparison between the classical V-model and the Agile/Iterative methods. Mr. Andy Tran, Head of Digitalization & CSV is looking forward to your attendance.