This European Annual Conference draws pharmaceutical and biopharmaceutical professionals at all levels of the industry - from students and emerging leaders to the most senior executives in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies.
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Our Industry Expert Jörn Volckmann together with the Industry Practice Lead from Tulip Gilad Langer are presenting an interesting use case:
Our industry is experiencing a true paradigm shift and we need to embrace change in order to capitalize on the promise of Pharma 4.0. The latest experiences with digital tools used for batch recording and digitization of GMP processes and procedures have shown significantly less effort spent in achieving compliance and decreasing cost of quality. This is because digital technologies can inherently provide compliance and finally take us out of the realm of paper documents.This presentation showcases how digital solutions provide easily accessible and interpretable documentation stored digitally and how compliance is built in, not an afterthought. Example solutions of how modern cloud based technologies capture batch record and other GMP data will be used to show what compliance looks like in the Pharma 4.0 paradigm. One of the cornerstones in these examples is the use of a risk-based approach and alignment with the CSA guidance. The presenters have used these methods and concepts in the industry and bring unique perspectives on how they can be adopted with examples and use cases. The presentation aims to educate the attendees on the inherent capabilities of digital technologies that support Pharma 4.0 and Validation 4.0.