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Stevens Institute of Technology Engineering & Science
Stevens Institute of Technology Chemical Engineering & Materials Science
Stevens CEMS
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Course Number: CHE 541
Course Name: Validation of Computerized Systems
Description: 

Computers and computerized systems are ubiquitous in pharmaceutical manufacturing.  Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation:  GMP, GCP, 21CFR Part 11, etc.  This course covers validation concepts for  various classes of computerized systems and applications used in the  pharmaceutical industry; importance of requirements engineering in validation;  test protocols and design; organizational maturity considerations.

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