Production Regulatory Affairs, Current Good Manufacturing Practice

BTC 2310 3 Quarter Hours
Course Level CPS - Undergraduate Quarter
Description Designed for degree and nondegree candidates. Presents the history of regulations and current interpretation of those regulations, including the CFRs, points to consider, and U.S. pharmacopoeia. Topics include considerations of implementation, including traceability, documentation responsibilities, personnel and process flow, segregation and labeling of products to prevent cross-contamination, quarantining and testing incoming reagents, in-process testing, sterility testing, environmental monitoring, facility requirements, QC testing, quality assurance functions, batch records, training records, gowning, and 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
  • 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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