A six-part series by Kelly Waldron, Ph.D., Sr. Consultant, ValSource
This series is intended to provide a holistic primer on the field of quality risk management (QRM). The following articles will provide background information for those new to the QRM discipline and will explore topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.