Category: Lab

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Building Effective Stability Protocols and Beyond

Presented by: John O’Neill, Stability information specialist, StabilityHub • What’s in a Stability Protocol?• What do you want them to do for your organization?• Who contributes to their formulation and quality?• How can they assure that you avoid compliance problems? This session explores this vital and often under-attended aspect of the Stability process and demonstrates […]

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An Overview of Good Laboratory Practice Regulations (GLPs)

Presented by: Stacy Wilson, MS- QA/RA Temple Adjunct Professor During this session the Good Laboratory Practice regulations (GLPs) will be introduced with a focus on Food & Drug Administration (FDA) 21 CFR part 58 and its application to nonclinical research. This session will offer a brief overview of the GLPs, discuss landmark cases that lead […]

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Avoiding Pitfalls When Acquiring Stability Rooms

Presented by: Stefan Cazzonelli, Sales and Marketing Manager, Parameter The purchase of capital equipment can be difficult and painful. Stability Rooms are not excluded from this process especially if you plan on acquiring multiple rooms at the same time. We will go over everything there is to consider when purchasing stability rooms from the equipment […]

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Stability Statistics in Practice – An Implementation Example

Presented by: Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc. Define what statistics belong in the Stability segment of a regulatory submissionWhat Regulatory Inspectors & Reviewers say about industry’s statistics programsBest practices for reporting statistical stability dataHow close can Stats Packages bring you to the completed report for submission?Review the common misapplications of […]

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