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 […]

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 […]

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 […]

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 […]