BT 108 - Regulatory Compliance

Credit Hours: 3

This course provides a basic understanding of the regulatory requirements to implement and maintain quality manufacturing practices to produce pharmaceuticals, medical devices and food.

Course Outcomes
Upon completion of this course, the student will be able to:

demonstrate an understanding of the bio-manufacturing industry, the impact and requirements of a variety of regulatory agencies especially the responsibilities and goals of the United States Food and Drug Administration (USFDA);
compare the similarities and differences of the FDA’s Good Manufacturing Practice (GMP) regulations for drugs, food processing and medical devices;
identify the regulatory inspection, complaint, recall processes with emphasis on the typical current regulatory issues facing industry and regulatory bodies;
describe the USFDA’s documentation requirements through the industry’s Good Documentation Practices (GDP); and
demonstrate understanding of the Food Safety Modernization Act (FSMA) and the regulatory guidances which resulted from this act.

F,S (N)