Nathalie’s Compliance Corner – Inspection readiness – first impression

Post Series: Nathalie’s Compliance Corner

I just spent the last three days at the DIA (Drug Information Association) Annual Meeting in Washington, DC. I had the opportunity to attend several sessions where speakers from different regulatory agencies (FDA, EMA, PDMA…) spoke about their expectations of GCP/Clinical Inspections.

As you can imagine, they were asked about their expectations, they were asked to comment on guidelines (like Risk-Based Monitoring), about risks, about quality systems…In the end, I was surprised, though I should have not have been, with the very simple take-home message: “We need to trust you, we need to trust your data, we need to know you protected the patients”.

Sounds simple enough, doesn’t it? So, why we do we get lost in the details and get overwhelmed at the idea an inspector looking at our stuff? How can we be more ready?

One of the regulators stated if your documentation is not well-organized and well-presented in your dossier and in your inspection documents, this will raise a flag…and they will dig. So, when the inspector shows up at your door, make sure your documentation is ready and well-organized and your people are trained and are confident to answer questions. Remember: you never get a second chance to make a first impression!

Tip: Skillpad has prepared a Premium Suite of four Inspection Readiness lessons to help you prepare for a Clinical Inspection. Using these lessons as part of your inspection preparations will help ensure your first impression is top-notch!

The lessons feature:

  • An innovative Project Management Approach to prepare your Team for an Inspection
  • Common inspection scenarios with pertinent examples
  • Current experience from actual Inspections
  • Commonly asked questions in Clinical Inspections
  • Tips and resources that will help Prepare your Team, reduce Risk and Findings, and increase Compliance

Skillpad help clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies.

Nathalie Bourgouin, PMP – Senior Consultant & Project Manager, Skillpad Canada Inc. –Compliance subject matter expert with an extensive background in risk-based quality assurance processes and training in clinical trials and manufacturing areas. Skillpad encourages an innovative integration of project management concepts into compliance.