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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Fall

Spring

Online

Starting at $999.00

As few as 11 weeks

4.0

3.3

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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.

Fall 2021 Schedule

September 20 - December 5

This section has no set meeting times.

Available

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Instructor: Bill Tawil

380870

Fee:

$999.00

Online

Updating...

Still accepting enrollments

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Notes

Enrollment limited; early enrollment advised.

Refund Deadline

No refunds after October 04, 2021

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.

Biotechnology Engineering

biotechnology-engineering-ce0583

Medical Device Engineering

medical-device-engineering-ce0579

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