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This presentation will focus on key strategies to ensure compliance with the new series of USP chapters that cover extractables and leachables for container closure systems: USP 661.2, 1663, 1664 and how they correlate to following additional topics:
Dr. Michael Ruberto is a retained consultant to Pine Lake Laboratories available to support all extractable and leachable studies, as well as the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging. Dr. Ruberto is an active member of various pharmaceutical groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems.
Complimentary breakfast will be served prior to Dr. Ruberto’s presentation. We look forward to your attendance.