Course Description
Immerse yourself in the world of biologics with an introduction to their health benefits and explore the stringent regulatory standards set forth by EMA, FDA, and beyond. Learn how to ensure quality and safety while navigating global guidelines. Gain a comprehensive overview of manufacturing drug substances and investigational medicinal products (IMPs), covering everything from quality assurance to process validation. Discover state-of-the-art facilities, equipment excellence, and strategies for precision in fill and finish. Develop a deep understanding of managing process changes, analytical methods for biologics, and the importance of release specifications compared to in-process control requirements. Navigate the regulatory landscape, define precision parameters, and implement continuous quality monitoring. Don't miss the opportunity to expand your knowledge and engage with leading experts in the field.
Quality Requirements for Biologics
Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
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Course Description
Immerse yourself in the world of biologics with an introduction to their health benefits and explore the stringent regulatory standards set forth by EMA, FDA, and beyond. Learn how to ensure quality and safety while navigating global guidelines. Gain a comprehensive overview of manufacturing drug substances and investigational medicinal products (IMPs), covering everything from quality assurance to process validation. Discover state-of-the-art facilities, equipment excellence, and strategies for precision in fill and finish. Develop a deep understanding of managing process changes, analytical methods for biologics, and the importance of release specifications compared to in-process control requirements. Navigate the regulatory landscape, define precision parameters, and implement continuous quality monitoring. Don't miss the opportunity to expand your knowledge and engage with leading experts in the field.
Quality Requirements for Biologics
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