{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin","description":"Welcome to the 39th episode of Automating Quality. Mandy Gervasio is your host, and she\u2019s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   In today\u2019s 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\u2019t 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\u2019s observations and suggests tips for making a useful internal inspection report.   Key Takeaways: 0:36 \u2013 Mandy introduces today\u2019s topic: GCP Inspection Readiness part 4: Closing the Inspection 1:54 \u2013 Nathalie details her background in pharmaceutical and biotech companies 3:45 \u2013 Nathalie recaps the first three phases: Preparation, Planning, Execute & Monitor 5:10 \u2013 Nathalie explains the key steps of the closing phase 6:45 \u2013Nathalie discusses the importance of preparing for the Close-Out Meeting and what you should expect 9:45 \u2013 Nathalie provides some guidelines for responding to the inspector\u2019s observations 13:05 \u2013 Nathalie shares her experience in regards to putting together the response 16:00 \u2013 Nathalie revisits the importance of the internal inspection report 19:29 \u2013 Mandy thanks Nathalie for being on the show and sharing her experience ","author_name":"Automating Quality","author_url":"https:\/\/docs.solabs.com\/hc\/en-us\/sections\/360006683193-Automating-Quality-Podcast","html":"