Guiding the pharmaceutical and medical device industries to successfully transition into the eras of AI/ML and Pharma 4.0, the presenters will provide tangible insights derived from GAMP and quality perspectives to ensure product quality, patient safety and data integrity. In this webinar, we will deliver key concepts and examples demonstrating the initial Concept Phase of the GAMP 5 Life Cycle with AI/ML sub-systems. We will describe how to map AI/ML solutions to business needs and perform initial risk assessments as published in the GAMP 5 Second Edition featuring further industry guidance all along. The five key principles of Transparency, Reproducibility, Interpretability, Applicability, and Liability will serve as guidelines during the first steps of the process. We will also provide the audience with use cases that clearly illustrate these AI concepts and technologies in both pharma and medical devices scopes. This webinar is first in a series to expand to the complete life cycle.