BME 450 - Regulatory and GMP

Institution:

West Chester University of Pennsylvania

Subject:

Description:

This course provides students knowledge of the processes in the manufacture or quality control of biotechnology products with current Good Manufacturing Practices (cGMP) guidelines and regulations. Topics include: introduction to the FDA and other regulatory agencies, current Good Manufacturing Practices (cGMP), process validation requirements and product life cycle quality management, and the application of the regulations to case studies.

Credits:

3.00

Credit Hours:

Prerequisites:

BME 325

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.wcupa.edu

Phone Number:

(610) 436-1000

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

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