Biomanufacturing Enterprise: Innovative Student Training in Quality Systems & Regulatory Compliance

Abstract: A Biomanufacturing Enterprise for Innovative Student Training in Quality Systems and Regulatory Compliance is authored by Vivian Ngan-Winward of Salt Lake Community College. This is an extended abstract conference paper for the ASQ Education Division's 2011 Advancing the STEM Agenda in Education, the Workplace and Society conference.

Biotechnology is a popular and growing science, technology, engineering, and mathematics (STEM) field that has ties to a number of industry sectors including agriculture, environmental and industrial sciences, and health care (including diagnostics, therapeutics,personalized medicine, pharmaceuticals, and medical devices). Students preparing for a career in biotechnology usually complete a considerable amount of STEM-related coursework that provides them with a solid and relevant technical knowledge base.

However,they are usually not ready to work within a quality system and regulated environment because they lack training in these areas. Food and Drug Administration (FDA) regulations require companies to address this gap. This training is typically provided in-house and on-the-job,but it is often inefficient and may jeopardize the organization's productivity. Thus, there is certainly enormous value in teaching quality and regulatory concepts to college students, to round out their career preparation efforts. Such subject matter is best learned through application. At Salt Lake Community College (SLCC), a student-run biotech manufacturing(biomanufacturing) business enterprise is being established to provide students with a supportive, real-world, and contextual hands-on training environment in which they can learn and put to practice quality and regulatory concepts and skills, as well as reinforce their biotech-related STEM knowledge.

Keywords: STEM - Teaching Quality - Community College - Hands-on Learning - Conference Proceedings