CAPA programs remain the #1 issue triggering warning letters.

And many drug and device companies remain hard pressed to understand what additional steps they should take to finally satisfy the FDA.

But the smart organizations have made a point to uncover how to proactively correct their problems, long before the inspectors arrive.

Now you can tap in to what they’ve learned — to FDA-proof your CAPA program.

New from FDAnews
Principles of an Effective CAPA System: A Guide for Device and Drug Companies

What are the secrets for turning a good CAPA system into higher quality products — and lowering the risk of FDA warning letters? 

Find out in this powerhouse new management report from FDAnews.

Whether you’re new to the quality profession or you’re a veteran looking to strengthen CAPA processes in today’s tougher enforcement climate, Principles of an Effective CAPA System: A Guide for Device and Drug Companies plugs you into best practices that help you avoid the investigation, documentation and corrective action mistakes that have landed so many other companies with warning letters.

Real-world guidance on
mastering one of the FDA’s toughest standards

Buy now to learn the art of implementing corrective and preventive actions that can help you sail through FDA inspections, including:

• A clear view of where CAPA systems most often fail — drawn from analysis of trends in FDA CAPA enforcement cases
• How to put CAPA processes into place at the clinical trial stage of drug and device development
• How to evaluate your existing CAPA system — before inspectors arrive
• Step-by-step advice for initiating and carrying out effective CAPAs
• Proven ways to enlist CAPA cooperation between various divisions
• How to balance a long-term commitment to CAPA with a corporate culture that demands quick solutions to complex problems
• Real-world tips for keeping CAPA systems running smoothly
• How to respond to FDA 483s and warning letters citing CAPA deficiencies
• A CAPA closure checklist
• Techniques for maintaining continued effectiveness after the CAPA is concluded

Buy Now
Principles of an Effective CAPA System: A Guide for Device and Drug Companies is offered by FDAnews in print and PDF format for $397. Act now: place your order here.

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