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. To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS […]
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• […]
Presented by: Hector Felix, Senior Validation Engineer at VTI Life SciencesThis 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 Mapping IntroductionWhy should […]
Created by: Christopher V. Latoz, Stability Manager, Hollister IncorporatedMany 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 vulnerability […]
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