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GXP (GOOD PRACTICE): WORKING IN A REGULATED ENVIRONMENT

PHMSCI 752
Course Description

The pharmaceutical and biopharmaceutical industries have strict documentation and production requirements. Prepares the learner to work in a regulated environment. Explains roles and responsibilities across multiple disciplines and proper documentation practices. Prepares learner for protocol, report creation and audit responses. Discusses specifications, guidances and root-cause analysis.

Prerequisties

Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development

Satisfies

This course does not satisfy any prerequisites.

Credits

3

Offered

Not Applicable

Grade Point Average
3.84

-1.6% from Historical

Completion Rate
100%

No change from Historical

A Rate
78.95%

-6.16% from Historical

Class Size
19

-9.52% from Historical

2025 Fall Grade Distribution

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