Practical Applications in Biomedical Product Global Regulatory Affairs

RGA 6300 4 Quarter Hours
Course Level CPS - Graduate
Description Uses a series of practical exercises and discussions designed to offer students an opportunity to exercise their ability to translate global regulatory requirements for pharmaceutical, biologic, and medical device product commercialization into submission-ready documents and broadly applicable regulatory science solutions. Topics include creating practical documents based on regulations and guidelines, completing production batch records, conducting product testing, performing inspections, and effective utilization of GxP requirements. Incorporates both group and/or individual assignments that require students to research applicable regulatory and industry information, as well as activities designed to aid in the comprehension of global regulatory issues. Uses case-based methodologies to enable real-world application of topics and regulatory issues discussed during the course.

Prerequisites

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.
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