Abstract
Biomedical core facilities are key resources supporting the academic research enterprise. As providers of analytical services and expertise with a commitment to rigor, reproducibility and data integrity, core facilities should be at the forefront of quality management and process improvement. Given the constantly changing research environment, an important competitive differentiator is the implementation of an operational quality management system (QMS). Additionally, cores involved in biomedical manufacturing may be subject to federal regulations, thus requiring a QMS. Linked to quality management is the adoption of quality assurance best practices to avoid unintended variation in laboratory results. This session will provide practical guidance and informative case studies for establishment of best practices and quality systems in core labs. Presentations will focus on (1) implementation of a quality management system in a genomics core facility; (2) a stepwise approach to building a quality system in a regulated academic manufacturing facility; and (3) establishment of risk-based quality assurance best practices as a strategy to reduce pre-analytical errors associated with sample quality and handling.