Attend Live on Wednesday, April 29th at 11 am ET/9 am PT
USP <382> represents a significant shift from component-based qualification to holistic evaluation of the complete parenteral packaging and delivery system. This webinar explores how responsibility for demonstrating functional suitability increasingly resides with the CDMO and finished product manufacturer, rather than the component supplier alone. Attendees will gain insight into system-level functionality testing, integration with container closure integrity testing (CCIT), and practical strategies for meeting USP <382> expectations throughout development and commercialization.
Key Learning Objectives:
Understand the responsibility shift under USP <382>
Recognize the importance of system-level functionality testing
Learn how functional testing and complete system CCIT work together
Who Should Attend:
CDMO and finished product manufacturers
Packaging, device, and combination product engineers
Quality, regulatory, and compliance professionals
Analytical and contract testing laboratory teams
Component and material suppliers
Christian Collazo-Sara, BS BME, Manager - Container Closure Integrity, Medical Device, and Package Testing
Pace® Life Sciences – Lebanon, NJ
Christian Collazo-Sarra is a manager at the Pace® Life Sciences laboratory in Lebanon, NJ focusing on CCIT, drug delivery device functional characterization, and package distribution testing services. He has over 7 years of experience in contract testing across multiple disciplines in the pharmaceutical industry and is a graduate of Rutgers School of Engineering, with a BS in Biomedical Engineering.