Created by: Chris Latoz & Kim Huynh-ba Combination 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 […]
Created by: John O’Neill, Facilitator, PSDG, Editor, StabilityHub.com Stability 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 […]
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, StabilityHub The 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 […]
Presented by: Emily Purchase, Project Manager, Quality, Compliance & Regulatory, CAI Having 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 […]
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