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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 $1,050.00

As few as 11 weeks

4.0

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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.

Spring 2025 Schedule

March 31 - June 15

This section has no set meeting times.

Future Offering (Opens February 03, 2025 12:00:00 AM)

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Instructor: Bill Tawil

402721

Fee:

$1,050.00

Online

Updating...

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Notes

Enrollment limited; early enrollment advised. Enrollment deadline: Apr. 6.

Refund Deadline

Refunds only available from February 03, 2025 to April 13, 2025

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

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Medical Device Engineering

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