Principles of Developing Drug- and Biologic-Led Combination Products

Master the practical operational strategies required to successfully develop, manufacture, and validate a drug-led combination product system without compromising product quality or launch timelines. Through real-world case scenarios, this course provides a hands-on blueprint for managing supplier risk, executing targeted extractables and leachables testing, and designing standalone human factors validation studies that prevent critical user error. This course will equip your cross-functional engineering and operations teams with the tactical skills necessary to integrate device quality requirements directly into core pharmaceutical cGMP environments, effectively eliminating line stoppages and hazardous product recalls.