BT 235 - Validation Science

Credit Hours: 3

This course emphasizes both regulatory and industry requirements for the implementation and maintenance of a validated process, assay, or system. The emphasis will be based on the requirements of the US Food and Drug Administration. The impact of risk and risk mitigation on the validation process assists key elements of the company’s quality system facilitating safe and consistent production of products. This course underscores the significance of the generation and maintenance of appropriate documentation supporting the quality system, enabling successful product launches resulting in the overall success of the company.

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

demonstrate an understanding of the impact and requirements 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 the industry utilizes the quality system concepts to convert FDA requirements to standard operating procedures, policies, and guidelines;
identify the regulatory inspection, complaint, and recall processes with emphasis on the typical current regulatory issues facing industry and regulatory bodies;
demonstrate an understanding of the FDA’s documentation requirements, the Industry’s Good Documentation Practices (GDPs); and
exhibit proficiency in developing a standard operating procedure on a product/process, generating a documentation change control that would meet US FDA and industry requirements.

Prerequisites: BT 108
F (N)