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 […]
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 […]
Created by: Christopher V. Latoz, Stability Manager, Hollister Incorporated Many laboratories have not taken the time to develop a disaster plan, or the plan they have created has not been reviewed or revised for several years. In this article, we’ll discuss key elements that should be incorporated in a laboratory disaster plan, including a hazard […]
Presented by: Gary Ritchie, Consultant, CAI • Stability test result deviations• Quality Management System (QMS) elements for1) OOT/OOS2) FDA notification Field Alert Report (FAR)3) Corrective Action/Preventative Action (CAPA) remediation plan• Statistically evaluate OOT• Hypothesis Testing & Root Cause Analysis• Conclude and document a root cause whenever possible• Tools used to trend stability data• Stability deviation […]
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