Category: Lab

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Medical Product Excursions from Labeled Storage Conditions

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 […]

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Stability Chambers Selection, Validation, and Calibration

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 […]

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Understanding FDA’s Revised OOS Investigation Guidance

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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Fundamentals of Temperature Mapping for Controlled Environments

Presented by: Hector Felix, Senior Validation Engineer at VTI Life Sciences This webinar will cover the best practices you must implement whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done, and how with real concrete examples and case studies. The course details will include: DefinitionTemperature […]

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