Welcome to the 36th 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!
On today’s episode of Automating Quality, 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 two in a four-part series.
In the previous episode, Mandy and Nathalie took a look at the initiation phase of GCP inspection readiness. This phased approach that Nathalie has put together has made it easy for listeners to synthesize this topic effectively.
Mandy and Nathalie know how technical and challenging it can be to maintain expertise in various areas. So, if you are fairly new to the life sciences industry this series will be incredibly beneficial in learning more about inspection readiness planning!
Be sure to tune in to the second part in this series as they focus on the planning phase of GCP inspection readiness and break down the key aspects.
[:32] About today’s episode, the second part in a four-part series.
[2:43] Mandy welcomes Nathalie back on the podcast.
[2:50] Nathalie brings listeners up to speed on what was previously discussed.
[3:55] Nathalie explains the project planning phase that follows the initiation phase.
[5:00] Nathalie details the three main tasks in the planning phase: preparing the plan, execution, and monitoring.
[5:50] Nathalie explains the goals of the inspection readiness plan.
[7:00] Nathalie walks listeners through the typical paths of actions that should be outlined in the readiness plan.
[10:45] Nathalie provides additional tips on key actions to consider when preparing your team for the inspection.
[13:21] Mandy emphasizes that it is normal and expected to refer to procedure during the audit. You are not required to know everything by heart!
[14:07] Nathalie gives her recommendations on general guidelines for interacting with inspectors.
[16:34] The do’s and don’ts when interacting with an inspector.
[18:43] Nathalie’s #1 piece of advice for interacting with an inspector.
[20:42] Mandy and Nathalie highlight the importance of knowing when to ask for help.
[23:02] Nathalie explains the last task of the planning phase: monitoring the deliverables.
[24:02] Mandy wraps up this week’s episode by thanking Nathalie, reflecting on today’s learnings, and announcing the next show in the series: the monitoring phase.
Mentioned in this Episode: