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For Corrective Action Plans, Where Are the Resources?

What sells at the FDA

The QA Pharm
Wed, 05/18/2011 - 05:30
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Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material before stepping into what they perceive to be hostile territory. Their presentations were carefully crafted by the vice president, senior vice president, and executive vice president, and vetted by the lawyers. Consultants who claimed to have “been there and done that” were invited to the prep meetings to give their insight into what “sells” at the FDA.

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When the meetings at the FDA are over, the firm’s representatives heave a sigh of relief and offer each other congratulations that it went well, because it “felt good.” It “felt good” because no one on the FDA side of the table objected or got upset. So they go back to their colleagues and claim victory. The story gets exaggerated and turns into something like, “They really liked our presentation.”

In my experience, the only thing that “sells” at the agency is results.

 …

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Comments

Submitted by shrikale on Wed, 05/18/2011 - 10:39

It's Not Complicated.

 

In many ways I'm still a neophyte when it comes to the FDA & quality systems regulations. But, you don't need to be an expert to answer the basic questions regarding a project:

  1. What is the action item?
  2. Who is responsible for it?
  3. When will it be completed?

These three simple things provide a basic plan.

I've worked for three different medical device companies now. Without fail, meetings generate actions items (that are never documented) that aren't ever explicitly assigned to anyone or have an explicit completion date. The attitude is "we know what needs to be done and we'll do it." How such businesses function or even thrive escapes me.

I am glad that the FDA has taken to "trust but verify" approach -- data driven. Maybe this will prompt management to stop spending precious time developing mesmerizing presentations full of fluff and honing the "sell". Instead, they might try using that time to actually perform value added work.

Regards,
Shrikant Kalegaonkar
twitter: shrikale

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