Process Development and Quality Systems for Biotechnology

BIOENGR X 431.3

This course provides an overview of drug development from molecule to product, manufacture to regulatory, and product launch.

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What you can learn.

Describe an overview of drug development from molecule to product, manufacture to regulatory, and product launch
Define and implement basic scientific principles in drug development
Recognize and apply quality management principles in drug development processes including GxPs, GLP, GMP, GDP, GCP, and GAMP

About this course:

Overview of drug development from molecule to product, manufacture to regulatory and product launch. Basic scientific principles in drug development are covered with an emphasis on quality management principles, focusing on GxPs, including GLP, GMP, GDP, GCP and GAMP.