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Process Development and Quality Systems for Biotechnology

process-development-and-quality-systems-for-biotechnology-bioengrx431-3
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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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.

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 2026 Schedule

Date
Details
Format
 
-
This section has no set meeting times.
Instructor:
Bill Tawil
REG#
407597
Fee:
$1,100.00
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Notes

Enrollment limited; early enrollment advised. Enrollment deadline: Apr. 5

Deadline
Refunds only available from February 02, 2026 to April 12, 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-header

Biotechnology Engineering

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Biotechnology Engineering

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-ce0579

Medical Device Engineering

certificate

Medical Device Engineering

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

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