{"id":1506,"date":"2022-07-11T04:40:22","date_gmt":"2022-07-11T04:40:22","guid":{"rendered":"https:\/\/people.utm.my\/chualeesuan\/?page_id=1506"},"modified":"2025-09-20T14:25:02","modified_gmt":"2025-09-20T14:25:02","slug":"sktb4133-quality-management-in-biomanufacturing-2021-2022-ii","status":"publish","type":"page","link":"https:\/\/people.utm.my\/chualeesuan\/sktb4133-quality-management-in-biomanufacturing-2021-2022-ii\/","title":{"rendered":"SKTB4133: Quality Management in Biomanufacturing (2024-2025-II)"},"content":{"rendered":"\r\n

CLO Course learning objectives:<\/strong><\/p>\r\n\r\n\r\n\r\n

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.<\/p>\r\n\r\n\r\n

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CLO1: Explain management and technical requirements of quality management system in biomanufacturing.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

CLO2: Assess scenario for validation or verification in biomanufacturing.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

CLO3: Evaluate resources to ensure the consistent operation of biomanufacturing plant for sustainability.\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

CLO4: Organize risk assessment outcomes using modern tool.<\/p>\r\n\r\n\r\n\r\n

CLO5: Demonstrate ethical and profesionalism in auditing.\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n

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Effective Management System<\/h2>\r\n\r\n\r\n\r\n

An effective and efficient management system is very important in any organization. Let us see what are the important elements to have such a successful and workable quality system in biomanufacturing or in company’s laboratory.<\/p>\r\n\r\n\r\n\r\n

Which management system is more appropriate to you ? Is the effective or efficient management system? and Why you prefer that system ?<\/p>\r\n\r\n\r\n\r\n

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THREE points would like to highlight here;<\/p>\r\n\r\n\r\n\r\n

(a). A clear and well defined organization structure with known responsibility and interrelationship in each function.<\/p>\r\n\r\n\r\n\r\n

(b). Appropriate facility and\/ or environmental conditions for operation\/ functioning.<\/p>\r\n\r\n\r\n\r\n

(c). Ensuring staff competency is always maintained.<\/p>\r\n<\/div>\r\n\r\n\r\n\r\n

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Please click on the link below to access the PowerPoint slides for further information.<\/p>\r\n\r\n\r\n\r\n

https<\/a>:\/\/drive.google.com\/file\/d\/1L-OqPaPx5MvCkoQ6LPJJXdQ0UHw1B374\/view?usp=sharing<\/a><\/p>\r\n\r\n\r\n\r\n

Feel free to send me an email (chualeesuan@utm.my) if you have anything would like to share.<\/p>\r\n\r\n\r\n\r\n

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Validation & Verification<\/strong><\/p>\r\n\r\n\r\n\r\n

Any differences ?<\/h2>\r\n\r\n\r\n\r\n