Welcome to the 35th 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 show is pretty exciting! Mandy is going to be revisiting a topic that Automating Quality covered a bit last season around the GCP space. Joining her to discuss this topic is a veteran guest of the show who previously introduced the GCP topic — Nathalie Bourgouin! Nathalie is the Vice President of Compliance at Skillpad, which is a sister company of SOLABS. With nearly 30 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies.
Nathalie is kicking off this episode as the first in a four-part series around GCP inspection readiness from a phased approach perspective. Each of the four episodes will take a look at inspection readiness from four different stages, with the first one being the ‘Initiation’ phase.
For those that have yet to be involved in an inspection or in inspection readiness planning, this episode will be especially beneficial!
[:33] Mandy introduces this episode’s topic.
[1:18] Nathalie Bourgouin introduces herself and provides a background of her career.
[2:29] Nathalie further explains the topic for today’s episode and the content the full four-part series will cover.
[3:07] Nathalie explains what inspection readiness truly refers to.
[5:04] What are the first steps you should take when a regulatory agency comes knocking at the door?
[7:09] Nathalie further defines the Initiate stage and explains why it is so critical.
[8:37] How is an inspection “confirmed”?
[10:11] Nathalie breaks down the Initiation stage from a task perspective.
[12:11] How does Nathalie identify the key players? What does the vetting process look like and how does she assign those roles?
[13:26] How Nathalie ensures all team members are feeling ready and comfortable for the inspection.
[15:43] Once the inspector has arrived, what should you expect?
[17:12] Mandy wraps up the first episode in the four-part series!
Mentioned in this Episode: