Welcome to the 30th 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!
Today’s episode is all about inspection readiness and distinguishing what that looks like from both the GMP side and the GCP side. And joining Mandy today is return guest, Nathalie Bourgouin! Nathalie is the Vice-President of Compliance at Skillpad — a sister company of SOLABS — where she leads the Compliance Consulting Group, with a focus on clinical trials and research compliance. She’s a very well-rounded, highly experienced expert in the space with more than 25 years of experience in pharmaceuticals and biotech!
In this episode, Nathalie highlights the key concepts regarding GxP inspection readiness, compares the differences between GMP and GCP inspection readiness programs, explains how a company can better prepare for an inspection, and even highlights some of the issues she often sees coming up in inspections.
Whether you are new to the life sciences space or are a veteran with many years of experience, you will gain something of value in today’s episode!
Key Takeaways:
[:28] About today’s episode!
[2:35] Mandy welcomes Nathalie to the podcast!
[2:46] Nathalie highlights key concepts regarding GxP inspection readiness.
[4:14] Nathalie compares GMP vs. GCP inspection readiness programs.
[5:05] How can a company get ready for an inspection?
[7:59] Nathalie highlights some of the issues that she commonly sees coming up in GMP regulatory inspections.
[12:42] How GCP inspections differ from GMP inspections as well as some of the key differences in the inspection process between the United States and Canada.
[18:59] Nathalie provides some key tips for preparing for an inspection.
[21:23] Nathalie’s tips for preparing individuals on your team for an inspection.
[24:45] Nathalie stresses the importance of identifying who your key people will be for the inspection and training them on what they should and should not say.
[27:50] Mandy thanks Nathalie for her input on the show and reflects on some of the key learnings.
Mentioned in this Episode:
Automating Quality Ep. 8: “The Specificities of GCP Quality Systems with Nathalie Bourgouin”
