Stefan Muench

Körber Pharma Consulting GmbH
Vice President Signature Offerings
Stefan Münch is Vice President Signature Offerings, shaping the current and future portfolio of Körber Pharma Consulting. He studied computer science and has more than 25 years of experience in SW development (MES) and as a consultant for the pharmaceutical industry, supporting organizations in their digital transformation.
In addition, Mr. Münch is a speaker, moderator, instructor, and author for topics like CSV, CSA, AI/ML, Pharma 4.0™, digitalization, QRM, SW development, cloud computing, and data integrity. He is a member of ISPE and chair of ISPE & VDI/VDE GAMP D-A-CH.

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Figure 1: Application of artificial intelligence across the value chain
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ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.