Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

Automating Quality

Welcome to the 39th 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 on the topic of clinical inspection readiness. This episode is the last in the four-part series. If you haven’t already tuned in to the previous three episodes, be sure to listen to those first before tuning into this one! In Part 1 Mandy and Nathalie discussed the Initiation phase, in Part 2 they discussed the Planning phase and in Part 3 they discussed Execution and Monitoring.

This week, they are discussing the Closing phase of clinical inspection readiness! Nathalie discusses the importance of the close-out meeting, provides guidelines for responding to the inspector’s observations and suggests tips for making a useful internal inspection report.

Key Takeaways:

• 0:36 – Mandy introduces today’s topic: GCP Inspection Readiness part 4: Closing the Inspection
• 1:54 – Nathalie details her background in pharmaceutical and biotech companies
• 3:45 – Nathalie recaps the first three phases: Preparation, Planning, Execute & Monitor
• 5:10 – Nathalie explains the key steps of the closing phase
• 6:45 –Nathalie discusses the importance of preparing for the Close-Out Meeting and what you should expect
• 9:45 – Nathalie provides some guidelines for responding to the inspector’s observations
• 13:05 – Nathalie shares her experience in regards to putting together the response
• 16:00 – Nathalie revisits the importance of the internal inspection report
• 19:29 – Mandy thanks Nathalie for being on the show and sharing her experience