GXP (GOOD PRACTICE): WORKING IN A REGULATED ENVIRONMENT
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 & course information
Requisites: Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Describe the laws, processes, and regulations associated with drugs, biologics, and medical devices in the United States. Audience: Graduate 2. Articulate and apply quality based systems in a GxP regulated environment. Audience: Graduate 3. Explain and analyze when and how the GxP requirements are applied over the course of the product life cycle. Audience: Graduate 4. Identify the key factors in GxP facility and equipment design, qualification, and maintenance. Audience: Graduate 5. Identify the key elements required to operate a compliant control laboratory. Audience: Graduate Learning Outcomes: 1. Describe the laws, processes, and regulations associated with drugs, biologics, and medical devices in the United States. Audience: Graduate 2. Articulate and apply quality based systems in a GxP regulated environment. Audience: Graduate 3. Explain and analyze when and how the GxP requirements are applied over the course of the product life cycle. Audience: Graduate 4. Identify the key factors in GxP facility and equipment design, qualification, and maintenance. Audience: Graduate 5. Identify the key elements required to operate a compliant control laboratory. Audience: Graduate
Sources
- Course catalogue ↗2026-2027