AI/ML in Regulated Life Sciences (GxP) Sectors - Project/Operation Phase: Computerized System Integration and Acceptance

Complimentary
Learning Level: Advanced
Time: 1000 - 1130 EDT 
Session Length: 1.5 hour

Guiding the pharmaceutical and medical device industries to successfully transition into the era of AI/ML and more generally Pharma 4.0, the presenters will provide tangible insights derived from GAMP and quality perspectives to ensure patient safety, product quality, and data integrity. We will build on the foundations presented in the first three webinars (a) business need and risk assessment, b) considerations on data sets and representativeness, and c) iterative training, fine-tuning and learning by discussing the sub-system and system integration, user acceptance testing as well as panning of deployment and monitoring of AI/ML solution. This webinar will describe how sub-systems can be integrated into back-end processes and front-end applications and how their effective use can be demonstrated considering a variety of use case examples. The webinar will cover machine learning (ML) integration with different types of computerized systems (CS): WebApps, Software, embedded in SaaS Applications, while considering respective challenges. This webinar will show particularities of user acceptance testing when implementing ML approaches in integrated solutions and risk management considerations relevant for the integration phase. Alongside the implementation aspects, the webinar will also elaborate on the necessity to plan the deployment process and monitoring procedures.

Learning Objectives

  • Provide a brief overview of the two lifecycles: ML sub-system and computerized system, highlighting critical risk aspects and including coverage of lifecycle of AI models of different complexity and purpose and integration aspects (incl. WebApps, Software, SaaS Applications, dashboards).
  • Explain MLOps methods and DevOps tools for Machine Learning, from concept to workflow, including considerations on end-to-end MLOps in conjunction with cloud providers.
  • Introduce various types of performance and user acceptance testing planning and execution strategies.

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Speakers

Taylor Chartier
CEO
Modicus Prime
Carsten Jasper
Director, Validations & Systems Operations Europe & Asia
Charles River Laboratories Inc
Laila Rasmy
Assistant Professor
UTHealth SBMI
Placeholder Person Graphic
Kathy Zielinski
Senior Principal – AI/ML Global Compliance Lead
Roche