Inspection Readiness from a GCP and GMP Lens

(Originally aired on 26 Nov 2019.  Duration: approximately 15 minutes)

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.

To speak with a Skillpad Compliance Expert about this topic and many others, you can contact: