Explanation should include
- regulatory agencies (e.g., Food and Drug Administration [FDA], U.S. Department of Agriculture [USDA], Federal Communications Commission [FCC], OSHA)
- quality requirements and standards (e.g., Good Laboratory Practices [GLP], Good Manufacturing Practices [GMP], International Standards Organization [ISO])
- distinguishing between quality assurance and quality control
- application of quality control to biomedical products.
Process/Skill Questions:
- Why are regulatory agencies such as FDA, USDA, FCC, and OSHA concerned with biomedical products?
- What is the difference between quality control and quality assurance?
- What are the origins of the guidelines for GLP and GMP?