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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.

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): 

• January 2010 — supply company cited for failure to: “document CAPA activities, i.e. trend analyses...” {820.10 cited}
   
• May 2009 — warning letter issued for: “Your firm had no documentation to demonstrate any trend analysis had been conducted in the past three years.” {820.20 cited}
   
• January 2009 — warning letter issued for: “Failure to analyze and trend nonconformances, complaints, and other sources of quality data...” {820.10 cited}

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:

• Highlights the key regulatory requirements and recent enforcement actions
• Reveals best practices to master a troubling regulatory standard
• Addresses sources of quality data, including minimums, and offers suggestions for company-specific measures
• Walks you through the principal trending and statistical methodologies
• Spells out tried-and-tested reporting tools, dashboards and management review techniques
• Furnishes practical advice on when (and how) to perform “deep dives” in search of meaningful data
• And much more!

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

1. Overview & Requirements
2. Warning Letter Analysis
3. Quality Data Sources
4. Trending Methodologies
5. Procedure Requirements
6. Tools
7. Summary

Buy Now!
Quality Data Trending: Requirements and Best Practices for Devicemakers is available in print and PDF format for $377 each. Order your copy.

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