Quality Control and Validation Issues

BTC 4450 3 Semester Hours
Course Level CPS - Undergraduate Semester
Description Introduces the regulations and guidelines affecting the development, production, registration, and sale of medical devices, diagnostics, pharmaceuticals, and biotechnology products worldwide. Focuses on why regulations are necessary, ethical considerations, and international standards. Offers practical instruction in the basics of quality control and process/facility validation for the biotechnology industry. Reviews appropriate regulations, including personnel and process flow, environmental and water testing, sterility testing, and incoming material and in-process testing. Other topics include the establishment of a master validation plan; description of facility, equipment, and process validations; and cleaning validations.


Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.


Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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