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PME 541 Validation of Computerized Systems

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.

Credits

3

Cross Listed Courses

CHE 541, ME 541

Prerequisite

Graduate Student or At Least Junior