The PQG evening virtual event for Trainee QPs, titled “Overview on Stability Studies Requirements and Handling Unexpected Stability Events,” took place on February 25th via Zoom, utilizing its breakout rooms feature to facilitate effective discussions.
Mick Stuart (Contract QP and RP/RPi) delivered a focused presentation covering the purpose of stability studies, the QP Study Guide requirements, essential QP considerations, and relevant ICH and other guidelines. He also provided a summary of regulatory findings and recalls associated with stability issues.
Following the presentation, attendees were divided into 8 small virtual groups to engage in Viva-type practice questions, simulating how to manage unexpected stability events. The high level of participation allowed attendees to discuss the impacts of stability events, elaborate action plans, and articulate their responses effectively.
As always, the presentation is available in the members area of the PQG website.
A heartfelt thank you to Mick Stuart and the PQG committee members for organizing this event, and special thanks to the attendees for their active participation and positive feedback.