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It's estimated that 75 percent of devicemakers conduct internal audits “only because we have to — to comply with FDA and ISO regulations.”
Some take unfortunate short cuts, using part-time auditors or letting their own management do the audits and write the reports.
No wonder so many inspections end with FDA 483s and warning letters.
You can do better — much better.
The new management report from FDAnews, Effective Internal Audits and Quality Control Units for Devicemakers, will show you how a strong internal audit program and quality control unit (QCU) can ensure your compliance with FDA requirements … plus reduce waste and redundancy … and even improve your business operations.
Establish a Successful Internal Audit Program and
You'll start by learning step-by-step what it takes to create and implement an effective, independent internal audit program and quality control unit (QCU).
Quickly, you'll begin to see how important internal audits can be for your organization as a proactive tool and not just a "reaction" to a requirement.
And, you'll come to understand the FDA's expectations of your QCU, how to set up your unit properly and in compliance, and how to fix any problems with an existing QCU.
Specifically, you'll learn:
Gain Understanding of Why Failures Occur —
Effective Internal Audits and Quality Control Units for Devicemakers also dissects areas of possible failure and provides practical insights into why an organization like yours may continue to have issues and receive citations.
That's why we've also included a thorough analysis of recent device industry survey data that will help you better understand weaknesses in your operation, diagnose your problems and prevent 483 observations.
You'll also get tried-and-tested 'working tools' that will help you take your internal audit capability to the highest level, including …
Best practices for writing good audit reports and communicating them to your team and management …
Sample audit report in a format that has been successfully used by numerous companies …
An invaluable, comprehensive audit frequency criteria template, and …
Actual warning letter citations from companies like yours, so you can learn from their audit mistakes.
There's no time like the present to address shortcomings you may have with your internal audit program or QCU.
Order Effective Internal Audits and Quality Control Units for Devicemakers TODAY.
Make your internal audit program and QCU a top priority — with a report that will ensure your success.
Order Your Copy Today!
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