Taylor Lee

Hi there! I'm Taylor, thrilled to meet you! With a Master's in Biomanufacturing and years of industry experience,I am glad to bring this introduction to cGMP in biopharmaceutical manufacturing course. Biologics are shaping the future of pharmaceuticals, making it crucial for professionals to grasp essential cGMP components.In this comprehensive online course, we will first introduce the basic background of cGMP and biopharmaceutical manufacturing. Then we will talk about the levels of the quality management system. Our main focus will be module 3 which dives deep into the key concepts in GMP following the 5P framework, which stands for product, people, premises, process, and procedure. Key concepts that will be discussed include aseptic processing, Quality by design (QbD), process validation, cleanroom requirements, control strategies, and more. Let's explore this dynamic industry together.