Medical Device & Diagnostic Industry Magazine
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Originally Published MDDI August 2005

NEWSTRENDS

Erik Swain

Device companies undergoing an FDA inspection should set up a war room during the process, attendees learned at June's Medical Design & Manufacturing East show in New York City.

The device company war room should serve a function similar to that of military war rooms, said David
A. Clark, president of Compliance

Specialists Inc. (New Iberia, LA). Usually applied to military and political campaigns, the term refers to a place where decision makers convene to discuss strategy and tactics.

But, he added, for device companies, the room should also be where all documents are reviewed before the inspector sees them, and all employees should be briefed before the inspector interviews them.

“Inspectors will tell you what they want to see, and by looking at the documents in the war room first, you can brainstorm about stuff that might look bad, and put a spin on it,” he said. “That doesn't mean lying or making excuses. It means figuring out how to justify why things happened a certain way. And during the process, you can circle back with different approaches or information that might make the inspectors view something in a less-severe light.”

A war room can also help a firm react appropriately when an inspector is on-site, he said. A firm needs to monitor where the inspector goes and what he or she sees, and it needs to assert its rights if the inspector asks for something he or she is not entitled to by law. However, the firm should not appear obstructive or adversarial. Therefore, having a war room is a way to allow a firm to review everything an inspector requests before giving it to him or her, yet still provide materials in a timely manner.

Another important task, Clark said, is “picking the right people to interface” with an inspector. People who like to talk extensively about their job and who tend to offer more information than necessary should not be allowed anywhere near an inspector, he said. All answers to the inspector should stick strictly to the scope of the question, so only people who can stay on topic should be designated to speak to inspectors. The reason, he said, is that FDA inspectors are trained in interviewing tactics by the Federal Bureau of Investigation and are extremely good at getting information a company doesn't want to give up. “They ask very open-ended questions, and allow you lots of room to hang yourself,” he said.

At the same time, a firm sometimes needs to get an answer from a talkative employee. If the people assigned to provide answers to the inspector cannot provide one, they should not guess or make something up. They should tell the inspector that they need to consult with someone who is an expert in that subject. If subject experts are too talkative or haven't been trained to interact with an FDA inspector, they should not be allowed to speak to the inspector directly. Rather, they should be interviewed in the war room, and their answers should be relayed to the inspector by those authorized to talk with him or her.

Clark also stressed the importance of preparing for an inspection long before it occurs, suggesting that firms should have a standard operating procedure on FDA inspections. “It is best to put together a booklet of information that should answer about 75% of the initial questions,” he said. “It should include things like organizational charts, lists of products, process flow diagrams, and the quality manual. This especially helps if inspectors show up unannounced and your key people aren't there.”
Other preparatory techniques he suggested include:

• Conducting mock FDA audits and bringing people from outside the firm to critique operations.
• Designating who is responsible for speaking to inspectors and giving them tours, and assigning a backup for each of those roles. This rule applies to everyone in the war room as well.
• Maintaining a neat, orderly appearance at all times. “Be aware of how your facility looks to outsiders,” he said. “First impressions are very important.”
• Having an SOP for receiving an FDA inspector when he or she first arrives, and contacting everyone in the firm who needs to be made aware of the inspector's arrival.

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