The Criticality Of Supplier Management And Keys To Improvement

By Lisa Helmonds and Myrna Russell

Medical device supplier quality management can be daunting for any quality group, especially when you have many suppliers in multiple geographic areas. The most significant risks to supplier quality are increased fragmentation and globalization of the clinical and commercial supply chain and an increased emphasis on cost control. Both of these risks can result in product made under non-good manufacturing practice (GMP) conditions, studies run under non-good clinical practice (GCP)/good laboratory practice (GLP) conditions, or intentionally adulterated material for the purpose of economic gain. Regulatory agencies expect the sponsor to know their responsibilities for outsourced services and ensure effective assessment of their suppliers before engaging their services. Learn how to simplify and strengthen your supplier management program with quality assurance through supplier risk management, tools for enhancing supplier oversight, and more.