Originally published in June 2015
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 we 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 an off-the-shelf Suite of four e-Lessons to help you prepare for a Clinical Inspection. Time to make sure your first impression will be top-notch! Lesson features:
Check out a descriptions of these Clinical Inspection e-Lessons and complete range of Clinical Trials GCP e-Lessons here:
Skillpad help clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies.
Nathalie Bourgouin, PMP – Vice-President Compliance, 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.
Questions? Want to discuss further? To contact Nathalie Bourgouin and the Skillpad Compliance Team, click here: