CLO Course learning objectives:
This course highlights the importance of a quality system in biomanufacturing processes/industries to meet customer satisfaction. The quality system will cover both management and technical elements according to the requirements of the International Organization for Standardization (ISO), other relevant standards and regulations for pharmaceutical, cosmetic and food industries. A clear organization structure with well-defined objectives and well-organized documentation system will ensure the competence of staffs and validity of product specifications for quality assurance. The introduction of this course will equip students with the knowledge of quality system applicable in various biomanufacturing industries.
CLO1: Explain management and technical requirements of quality management system in biomanufacturing.
CLO2: Assess scenario for validation or verification in biomanufacturing.
CLO3: Evaluate resources to ensure the consistent operation of biomanufacturing plant for sustainability.
CLO4: Organize risk assessment outcomes using modern tool.
CLO5: Demonstrate ethical and profesionalism in auditing.
