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Created by: Chris Latoz & Kim Huynh-baCombination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway and compliance with a minimum […]
Created by: John O’Neill, Facilitator, PSDG, Editor, StabilityHub.comStability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of […]
Presented by:Laura Pack, Senior Director, Quality Control and Statistics, Rezolute, Inc.Kenneth Miller, Director, Global Stability and CMC Analytical Data Management, BioMarin Pharmaceutical, Inc.Watch a panel of analytical experts discuss the current hot topics, issues, and industry practices of the Analytical Laboratory.
Presented by: John O’Neill, Stability Information Specialist, StabilityHubThe right chamber for the right application takes your organization from samples to registration and beyond. Whether operating your own or using that of a contractor you’ll want to make sure the chambers you use won’t let you down. This session takes a User’s point of view in:• […]
Presented by: Emily Purchase, Project Manager, Quality, Compliance & Regulatory, CAIHaving a diverse group of suppliers can provide the expertise and innovation needed to outperform the• Establish stability protocols to deliver the right analytical informations• Establish key information to manage changes to the stability programs• Identify and investigate stability deviations to support product stability profile• […]
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