Since 2009, warning letter citations make clear that it's no longer enough for you to look back at the data and then react to quality problems.
You are now expected to trend your quality data.
New from FDAnews
Quality Data Trending:
Requirements and
Best Practices for Devicemakers
Quality Data Trending:
Requirements and
Best Practices for Devicemakers
In fact, the FDA wants you to maintain a 24/7 state of control by proactively monitoring your quality systems.
And compliance isn't optional, despite the fact that your information sits isolated in "data silos" like complaints and OOS — making your task of identifying trends nearly impossible.
How serious are they? Consider just three recent examples (with emphasis on trend added):
How serious are they? Consider just three recent examples (with emphasis on trend added):
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Your company may not have received such a citation ... yet. But every FDA inspection includes scrutiny of quality measurement and trending mechanisms. The time to beef up your procedures is now. Announcing the publication of Quality Data Trending: Requirements and Best Practices for Devicemakers.
This all-new special report from FDAnews shines the spotlight on this essential, but often neglected, area of quality control. In plain English, it:
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Concerned about whether your data analysis methods will pass FDA muster? Stop worrying — and do something about it. Order your copy of Quality Data Trending now!
Chapter List
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Buy Now!
Quality Data Trending: Requirements and Best Practices for Devicemakers will be published in May 2010 in print or PDF format for $377. Order your copy today. (Add $10 shipping and handling per book for printed books shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5 percent sales tax.)
Quality Data Trending: Requirements and Best Practices for Devicemakers will be published in May 2010 in print or PDF format for $377. Order your copy today. (Add $10 shipping and handling per book for printed books shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5 percent sales tax.)
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Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the Guide? Return the hard copy within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the Guide? Return the hard copy within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
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Please mention priority code 10902 when ordering.
Please mention priority code 10902 when ordering.
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