- Course Number:
- BIT 125
- Course Title:
- Quality Systems in Bioscience Technology
- Credit Hours:
- Lecture Hours:
- Lecture/Lab Hours:
- Lab Hours:
- Special Fee:
Course DescriptionIntroduction to internal and external quality systems that apply to the bioscience industry, with emphasis on working in a regulated environment. Also covers various agencies that regulate the bioscience industry, FDA regulation for good laboratory and manufacturing practices (GLP and cGMP), and processes relating to product approval. Audit available.
Intended Outcomes for the course
Use an understanding and appreciation of the importance of quality systems and regulatory compliance to work effectively and within established parameters in a regulated bioscience laboratory or biomanufacturing environment
Outcome Assessment Strategies
A. Identify and detail the roles played by regulatory agencies with authority over the development and manufacture of new biotechnology products/processes in several areas: drugs, biologics, devices, analytical processes, agricultural products (food or otherwise).
B. Create a Standard Operating Procedure (SOP) for a laboratory process. Also, review an existing SOP; identify and correct deficiencies.
C. Design a quality system for the development and manufacture of a potential biotechnology product (drug, biologic or device)
D. Anticipate quality system breakdowns in an actual case or realistic scenario, and identify appropriate remedies.
E. Participate in, and contribute to, all class discussions and activities.
F. Complete homework assignments and reports and all scheduled examinations.
Course Content (Themes, Concepts, Issues and Skills)
A. Classification of products
B. Activities and jurisdiction of federal regulatory agencies (FDA, USDA, EPA)
C. Key elements in quality systems
D. Obtaining regulatory information and direction
E. The may faces of documentation
A. Interpretation of federal regulations
B. Method development
C. Monitoring quality
D. Change Management
E. Personnel training
F. Approval processes for new products
A. Quality Systems in the laboratory and in a production facility
B. The critical nature of documentation