Practical Applications in Global Regulatory Affairs

Catalog description

Offers students an opportunity to exercise their ability to translate global regulatory requirements for globally regulated product commercialization into submission-ready documents and broadly applicable regulatory science solutions. Uses didactic instruction and a series of practical exercises and discussions. Topics include creating practical documents based on regulations and guidelines, formulation development, 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 scientific and technical application of topics and regulatory issues discussed during the course.