Medical device manufacturers often dread the FDA inspector’s arrival. But here’s a shortcut to success you can master in an hour or so. Please read on …
There is a little-known secret: Five problem areas account for one-fourth of all Form 483 observations the FDA issues devicemakers in a given year. Master these and you’ve taken a giant step toward inspection success.
And now, FDAnews has created a management report focusing on just those five areas.
Here are the five problem areas: corrective and preventive action, complaint handling, medical device reporting, purchasing controls and process validation. In 2012, the FDA cited deficiencies in these five areas in more than 1,100 instances, including:
Troubleshooting Your Quality System lists specific questions on each topic area for quality managers to ask when preparing for an FDA inspection.
We’ll walk you through the requirements for the five compliance hot spots and drill you on the questions that help you determine whether your own systems meet FDA standards. Those questions include:
Don’t risk incurring a 483 — not when it’s so easy to take the shortcut to inspection success. Order your copies of Troubleshooting Your Quality System today.
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