Everyone is talking about AI and it seems that no one can escape the hype surrounding ChatGPT, CoPilot and the like. Hopes are high that the new tools are actually intelligent and can not only make our lives easier, but also do the work for us. A brief excursion into how AI works will provide the basic understanding needed to better understand the potential applications in practice. Practical examples are used to illustrate the benefits and pitfalls of implementing AI. Once the introduction has been mastered, the question often arises - what happens next? How do I explain it to the authorities?
The presentation is based on several years of experience in the development, implementation and validation of AI solutions in GMP production and a workshop with the German-speaking regulatory authorities on the topic of AI in the pharmaceutical industry.