Quality Control and Validation Issues

Catalog description

Introduces the regulations and guidelines affecting the development, production, registration, and sale of medical devices, diagnostics, pharmaceuticals, and biotechnology products worldwide. Focuses on why regulations are necessary, ethical considerations, and international standards. Offers practical instruction in the basics of quality control and process/facility validation for the biotechnology industry. Reviews appropriate regulations, including personnel and process flow, environmental and water testing, sterility testing, and incoming material and in-process testing. Other topics include the establishment of a master validation plan; description of facility, equipment, and process validations; and cleaning validations.