Nathalie's Compliance Corner

The CRO or Sponsor wants a "Quality" Clinical Trial - time to stop hoping for the best, and define some metrics and an escalation mechanism... Originally published in 2014

How much has changed in Clinical CAPA in the past few years...not as much as you think - but we can fix that... Originally published in 2016

The Inspector is about to ask for our Training Records...are you ready? You could have used an innovative approach to prioritize which SOPs are assigned based on 2 criteria...read to find out more... Originally published in 2014

Are you and your team ready for a regulatory inspector to show up any time? They might... here are some thoughts on being prepared. Originally published in 2015

Someone recently asked me for a clear definition of a 'Standard Operating Procedure'...Doesn't everybody know what those are? Originally published in 2014

I sometimes get asked the innocuous sounding question: Compliance Expert - what is it that you do? Then the fun begins... Originally published in 2015

Skillpad's VP Compliance, Nathalie Bourgouin, shares her thoughts on Inspection Readiness. Originally published in 2015