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
Duration
As few as 11 weeks
Units
4.0
Current Formats
Online
Cost
Starting at $1,100.00
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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.
Fall 2026 Schedule
Date
Details
Format
-
This section has no set meeting times.
Online
Notes
Enrollment limited; early enrollment advised. Enrollment deadline: Sep 27, 2026
Deadline
Refunds only available from July 27, 2026 to October 04, 2026
Course Requirements
Book:
Medical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness
by Susanne Manz
ISBN 9780128142219
Internet access required to retrieve course materials.
This course applies toward the following programs
Biotechnology Engineering
certificate
certificate
Learn the fundamentals of biotech engineering, including design, manufacturing, quality and regulatory requirements.
Learn the fundamentals of biotech engineering, including design, manufacturing, quality and regulatory requirements.