IT Basics for Artificial Intelligence - Live Online Training

IT Basics for Artificial Intelligence - Live Online Training

Course No 21231

 

Costs

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Speakers

Christophe Girardey, wega Informatik, Basel, Switzerland
Stefan Münch, Körber Pharma Consulting, Karlsruhe, Germany
Yves Samson, Kereon, Basel, Switzerland
Nicolas Schaltenbrand, Wega Informatik, Basel, Switzerland

Objectives

Why should you participate in this event?
  • You will learn the basics of AI / ML and its applicability in the GxP Environment
  • How can pharmaceutical basics, e.g. risk management and qualification / validation be applied to AI? You will experience first approaches!
  • Are relevant pharmaceutical regulations adapted to this new technology and what expectations does an inspector have during an inspection? First concepts will be presented!
  • In case studies, pharmaceutical companies show first practical and practised approaches to the use of AI

Background

At the latest, artificial intelligence (AI) has arrived in the General public since ChatGPT and Bard. Opinions range between absolute euphoria and the invocation of the downfall of humanity. The foundations of AI were laid many years ago and can now be widely implemented due to massively available computing power. The topic has also found its way into the pharmaceutical landscape. First applications have come into operation. The interesting questions here are whether and how this technology is compatible with pharmaceutical regulations, specifications and authorities’ expectations.

Target Group

The Live Online Training is aimed at managers and QA members as well as engineers from the pharmaceutical industry, suppliers and service companies who qualify and operate AI applications in a GxP environment.

Technical Requirements

We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary Installation is fast and easy.

Programme

Introduction to Artificial Intelligence (AI)
Stefan Münch / Yves Samson
  • History of AI
  • Types of AI
  • Real life examples
Introduction to Machine Learning (ML)
Stefan Münch / Yves Samson
  • Technological Basics
  • Different learning / training Methods
  • Example use cases
AI/ML in Pharma, Biotech and Med Devices
Stefan Münch / Yves Samson
  • Challenges for pharmaceutical Industry
  • The GAMP-perspective on AI/ML
  • GMLP: SDLC for AI/ML
  • Use cases / Known scenarios
Data Science as Basis for AI
Nicolas Schaltenbrand & Christophe Girardey
  • Pre-requisites for AI: Data Governance, Data Science, Data Understanding, FAIRification.
  • Specificities in the lab
    • Lack of standardization, Lack of connectivity.
    • Chances with standards: AniML, SiLA
  • Specificities in clinical development
The Regulatory Landscape for AI/ML
Stefan Münch / Yves Samson
  • US / FDA: Expectations and guidance
  • EU / EMA: Expectations and guidance
  • Special case: Generative AI

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