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 encourage all who seek formal education in project management to take this certificate program. It is not for the inactive participant who seeks only to soak up the knowledge. The courses challenge you to step up and contribute effectively."
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