Welcome to the 37th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
In today’s episode, Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing last week’s topic on clinical inspection readiness. This episode is part three in the four-part series. If you haven’t already tuned in to the previous two episodes, be sure to listen to those first before tuning into this one! In episode one, Mandy and Nathalie discussed the initiation phase, and in episode two, they discussed the planning phase.
This week, they are discussing the execution and monitoring phase of clinical inspectional readiness! Nathalie gets into the details of the various considerations and different stages of this phase and breaks down some of the most important key aspects. This phase is all about what to do once the inspector actually arrives — so don’t miss out on learning more about this crucial step!
Key Takeaways:
[:31] About today’s episode, the third part of the four-part series.
[:45] Mandy recommends listening to the previous two episodes before tuning into this one.
[1:00] Mandy welcomes Nathalie back on the podcast.
[1:29] Mandy introduces the third phase: execute and monitor.
[1:42] Mandy thanks Nathalie once again for joining the podcast!
[2:08] Nathalie brings listeners up to speed on what was discussed in previous episodes.
[2:34] Nathalie introduces the topic this week: the execution and monitoring phase.
[3:04] Nathalie highlights the key tasks during the execution and monitoring phase.
[4:43] Nathalie explains how to pull the necessary data together for the first task: gathering the known issues and the available intelligence.
[6:11] Nathalie gives her advice regarding preparing a list of potential GCP issues.
[7:44] The key documents that need to be prepared prior to the inspection.
[10:56] Nathalie highlights some details regarding inspection expectations and shares what the day of the inspection will likely look like.
[12:46] Nathalie gives best practice advice for making sure things move along as planned.
[14:40] Nathalie provides further insight into monitoring progress and the identification of issues.
[16:02] About the final episode in the four-part series covering the final phase: closing the inspection.
[16:23] Mandy thanks Nathalie for sharing her insights in this episode and reiterates what the next and final episode in the series will be covering.
Mentioned in this Episode:
