AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment

Learning Level: Basic
Time: 1000 - 1100 ET 
Session Length: 1 hour

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.

Learning Objective

  1. Provide an overview of AI and ML concepts including common definitions that will form a foundation for the webinar series. Categorization of AI models according to technology, and application - including supervised vs unsupervised, static vs adaptive - will be described using recognized terminology.
  2. Share actionable insights and examples of the Concept Phase from AI applications in pharma and medical device industries.
  3. Provide tips on the selection of risk assessment methods


Eric J. Staib
Vice President, Corporate Quality
Placeholder Person Graphic
Katarzyna Zielinski
Compliance Intelligence Lead
F. Hoffmann La Roche Ltd
Nico Erdmann, PhD
Senior Manager
Deloitte GmbH WPG