April 2013

For Medical Device Companies

Creating, Staffing and Managing an Inspection War Room

by: Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.

Many companies in the life science sector hear their own version of "sound general quarters!" from FDA and anxiously await the ultimate examination: An inspection visit by the FDA. One of the key components of hosting such an inspection is the preparation and use of a "war room" during the visit. It can be referred to as the primary line of defense in the success of such a visit.

This strategic office should be devoted and organized to provide the necessary objective evidence requested during such an inspection. One of the key observations the inspector will make is the timeliness of the turnaround of a request. A speedy response is always favorably acknowledged and a well-organized war room makes that possible.

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How Social Media is Advancing Healthcare

by: Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants Inc.

Because of its 2012 IPO, Facebook has lately received a lot of media attention. While the news has been mostly financial, the huge sums of money being discussed are not the only numbers that can give pause. Facebook boasts a staggering 900,000,000+ users. To put that in perspective, if Facebook were a country, it would be the third largest in the world. And while Facebook is the biggest, it's not the only social networking giant. Depending what source you consult and how you count, there's another dozen or so social media sites with 100,000,000 or more active users. It's hard to believe that, as little as seven years ago, Facebook was still in its infancy, unavailable to the general public, and many of the other popular sites didn't yet exist. Journalist Tom Friedman humorously observed that, "way back then," Twitter was just a sound, the Cloud was something in the sky, applications were something you sent to college, and Skype was a typo.

It's barely possible to exaggerate the extent to which the Internet has influenced every aspect of our world, so, of course, healthcare is no exception. For example, the FDA recently announced that it is considering expanding the definition of nonprescription drugs, in part because of the wealth of health-related resources available on the Internet. Janet Woodcock of the FDA said, "The rules for nonprescription status were established in an age when widespread access to information technology did not exist. The world is evolving."

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