Simplifying Global Compliance
Using ISO 11607 to Develop Risk-Based Device Packaging
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So did Customed, Inc. — until it was hit with a record-breaking recall of 233 Class I products, representing several hundred thousand units.
All because of packaging flaws. Was Customed an industry outlier? An isolated case? Not really. From 2010 to 2012, flawed packaging was cited in nearly 400 other Class II and Class III recalls. These citations demonstrate once again that building packaging quality systems and deploying packaging engineering are not simple tasks. Are you on top of the best practices you need to design and create your packaging correctly — every time? If you're concerned — and you should be — there's a new management report from FDAnews that can help you. Using case studies and other frontline knowledge, Using ISO 11607 to Develop Risk-Based Device Packaging will show you how to leverage a risk-based packaging approach to prevent recalls and nasty audits … without busting a hole in your compliance budget. With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers. You'll also learn why your packaging might be at risk — and what you must do to reduce field complaints, recalls or FDA enforcement actions. With the knowledge you'll gain from this report, you will quickly find out how to:
Most importantly: You'll find out the real specifics that FDA investigators consider when they’re debating if it’s time to recall your product. That's why ordering this report is a no-brainer. Let the experts at FDAnews help you better understand what's at stake for your company and why risk-based packaging can make all the difference. Order Your Copy Today!
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