November 2013

For Medical Device Companies

FDA Inspections: Ensure Quality and Compliance

by Michael R. Hamrell, MORIAH Consultants

You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? With proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

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Grid Analysis for Simplified Supplier Selection

by Jennifer Stepniowski, Pro QC International

The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable. Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs. Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

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The Importance of Communication in Clinical Trials

by Rebecca York, PPD

As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented!) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.

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