Validation of Computerized Systems (PME/ME/CHE541)

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.


I just completed my Graduate Certificate in Project Management and I strongly recommend the Stevens’ WebCampus curriculum to anyone interested in improving their academic credentials while working full time. WebCampus offers flexibility, challenging and informative lessons, and an education that can actually be used in the real-world workplace. Denise O’Brien, Project Manager, AT&T"
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