Process Development and Quality Systems for Biotechnology
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.
Typically Available
Fall
Spring
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What you can learn.
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.
This course applies toward the following programs
Biotechnology Engineering
certificate
certificate
Learn the fundamentals of biotech engineering, including design, manufacturing, quality and regulatory requirements. Format: Online
Learn the fundamentals of biotech engineering, including design, manufacturing, quality and regulatory requirements. Format: Online
Medical Device Engineering
certificate
certificate
Master the fundamentals of medical device engineering, including design, manufacturing, quality control and regulatory requirements. Format: Online
Master the fundamentals of medical device engineering, including design, manufacturing, quality control and regulatory requirements. Format: Online