Quality and Customer Driven Innovation (BUSA90528)

Biotechnology enterprises are reliant on meeting strict quality guidelines governed by regulatory frameworks and in some cases legislation. All their products in addition to meeting stringent quality standards also need to meet customer needs to maintain the enterprises’ competitiveness. This subject will demonstrate how these two drivers can be integrated into an approach where quality products are produced meeting customer needs. The subject will cover a range of topics including design of products, customer driven innovation principles, prototyping from a customer perspective, relationship of prototype to commercial product, meeting regulatory and quality drivers in development and manufacturing. Six Sigma and lean product development and manufacturing will be considered in the context of customer driven innovation. The relevance of good manufacturing practices and validation to ensure manufacture of a consistent product meeting customer needs will also be covered. The options for the assessment-based learning include three different specialist areas of biotechnology – therapeutics, medical devices and food & agriculture. Students will receive expert support in these areas to engage in active learning in completing the assessment tasks.