Portland Community College | Portland, Oregon

Upon successful completion of the course students should be able to:

1. 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.

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.

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

THEMES
A. Quality
B. Documentation
C. Validation
D. Professionalism
E. Honesty

ISSUES
A. Interpretation of federal regulations
B. Method development
C. Monitoring quality
D. Change Management
E. Personnel training
F. Approval processes for new products

CONCEPTS
A. Quality Systems in the laboratory and in a production facility
B. The critical nature of documentation