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October 2011

Holly Scott

What to Expect When They're Inspecting - Part I

by Holly Scott
Biologics Consulting Group, Senior Consultant, and Former CBER Consumer Safety Officer and FDA Field Investigator

The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

One expects variations in the level of coverage at firms in different program areas, whether it's drugs, devices, biologics, dietary supplements, clinical research, or a food firm, because each industry area is so technically diverse. However, observation methods used by Investigators should be comparable and not diverge significantly. If two firms are manufacturing the same regulated product, and are both undergoing a routine GMP inspection, why does one receive an FDA-483 citation for an observation while the second firm receives no citation although the same observation was made? Is it a lack of continuity between Investigators, or are there other contributing factors?

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Rebecca York

Good Clinical Practice: From Review to Application

by Rebecca York
Clinical Research Associate, IMARC Research

As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

Good clinical practice is an attitude of credible excellence in research that provides a standard for clinical study design, implementation, conduct and analysis. Good clinical practice is more than any one document; rather, it is a collective compilation of many thoughts, ideas and learning moments spanning the globe over. Furthermore, good clinical practice is a mindset that is absolutely essential to the protection of patients' rights and the assurance of data integrity.

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Did you know that you can comment on a recent FDA draft guidance regarding mobile medical applications? Through a draft guidance released on July 19, 2011, the FDA defined a small subset of mobile medical apps that may impact the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.
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