Temple University 3 credits QARA
Since the concept of "validation" originally appeared in GMP regulations, it has extended to every step in product manufacturing from building the plant to the methods used for testing and releasing its products. The course exposes students to all aspects of validation. FDA Guides and Guidelines, as well as the current emphasis on validation concerns by FDA (as identified in 483 and Warning Letter observations), will be incorporated. Students develop acceptable validation protocols and learn what constitutes an acceptable validation report.
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