R&D Regulatory Affairs, Good Laboratory Practice

BTC 2320 3 Quarter Hours
Course Level CPS - Undergraduate Quarter
Description Designed for degree and nondegree candidates. Presents the history and current interpretation of regulations involved in development of new biotechnology products. Focuses on the issues critical to research and process development prior to licensure of biologic, drug, and device products by the FDA. Topics include the transition from GLPs to cGMPs as a product moves through clinical trials and offers students the opportunity to gain a basic understanding of auditing clinical trials.


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
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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