Title: Process Design Standards and Regulatory Affairs
Credits: 10
read more »provide learners with a fundamental understanding of EU and international regulatory systems required during process design. The module will cover the role of regulatory affairs, classification, regulatory structure, and the impact of various regulated industry submission pathways such as medical devices, pharmaceuticals, biopharmaceuticals, and Food manufacturers.
Title: Product Design Control
Credits: 10
read more »The learner will understand the importance of achieving the user needs and the linkage between each stage of the Design Control process from Design Input, Design History File, Design and Development Planning, Product Risk Management, Human Factors and Usability Engineering, Design Review, Design Output, Design Validation/Verification, Design Change and Design Transfer.
Title: Quality Management
Credits: 10
read more »Draws from International Standards for Quality Management, teachings of the various quality Gurus, National and International Quality Awards, and self-assessment models. Learners will develop skills to become leaders and innovators in the application of Quality principles techniques and develop as quality management professionals in the service and manufacturing industry.