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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.

Prerequisites

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

Satisfies

This course does not satisfy any prerequisites.

Credits

Not Reported

Offered

Not Reported

Grade Point Average
3.68

-3.91% from Historical

Completion Rate
96.67%

-2.28% from Historical

A Rate
63.33%

-18.19% from Historical

Class Size
30

29.03% from Historical

Cumulative Grade Distribution

Instructors (2026 Summr)

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