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.
Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
Need Extra Print Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.
3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
Copyright ©2018. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing