BT 235 - Validation Science

Credit Hours: 3

This course emphasizes the regulatory and industry requirements for implementing and maintaining a validated process, assay or system. The emphasis will be on the requirements of the US Food and Drug Administration. The impact of risk and risk mitigation on the validation process is explored with emphasis on assisting other elements of the company’s quality system to facilitate the production of a product in a safe and consistent manner. An understanding of the importance of generating and maintaining the appropriate documentation to support the quality system, the success of a product launch of products to market and the overall success of a company.

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

demonstrate an understanding of the biomanufacturing industry, the impact and requirements of a variety of regulatory agencies especially the responsibilities and goals of the US FDA;
exhibit an understanding of the FDA’s GMP regulations for drugs and medical devices and how industry utilizes the quality system concepts to convert FDA requirements to standard operating procedures, policies and guidelines;
identify the regulatory inspection, complaint, recall processes with emphasis on the typical current regulatory issues facing industry and regulatory bodies;
demonstrate an understanding of the FDA’s documentation requirements, Industry’s Good Documentation Practices (GDPs); and
develop a standard operating procedure on a product/process and generate a documentation change control which would meet US FDA and industry requirements.