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.