Drug-device combinations with complex controls or unexpected device operation can lead to increased patient risk. Combination Products Risk Management integrates human factors and other control strategies to enable effective design that promotes human well-being and overall system performance.

As pharmaceutical companies develop combination products, new and complex interactions among packaging components and delivery systems arise. It is critical to understand the compatibility and performance of the primary packaging system with both drug product and delivery systems for successful development of the control strategy. Developing and applying a strategy for component and system qualification helps ensure drug product quality, safety and efficacy. Manufacturers must understand chemical compatibility and the physical and functional aspects of these components and devices as a single system. Several key areas should be considered for analytical testing during development, namely: compendia, biocompatibility, extractables and leachables, container closure integrity, performance, potential particle generation and stability analysis.

Featured Speakers

Susan Neadle

Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

Susan Neadle is currently Sr. Director, Global Value Chain Quality Design at Johnson & Johnson, leading the J&J Cross-sector Design Council. She and her team provide Quality Engineering, Design-Excellence, and Risk Management guidance and subject-matter expertise over a range of product and process technologies for J&J. She drives and manages change, ensuring focus on customers, and fit-for-purpose, risk-based quality and reliability across product-realization processes. In addition to these responsibilities, Susan leads the J&J Combination Products CoP.

Jennifer Riter

Sr. Director, Lab Services
West Pharmaceutical Services, Inc.

Jennifer blends knowledge of pharmaceutical systems and components with hands-on experience with delivering technical support and analytical solutions for packaging and delivery systems. Jennifer has presented at symposiums on analytical testing of parenteral packaging components and systems. She is a member of the Board of Directors for the Lock Haven University Foundation, AAPS, PDA, and HBA. She earned a B.S. in Biology/Chemistry from Lock Haven University and an MBA in Pharmaceutical Business at the University of the Sciences in Philadelphia.


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