Troubleshooting Your Quality System

PDF Edition - Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

July 2013
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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:

  • 21 CFR 820.100: Corrective and preventive action (CAPA) procedures and documentation (487 citations)
  • 21 CFR 820.198(a): Complaint procedures (259 citations)
  • 21 CFR 803.17: Medical Device Reporting (MDR) procedures and documentation (140 citations)
  • 21 CFR 820.50: Purchasing controls (126 citations)
  • 21 CFR 820.75(a): Lack of or inadequate process validation (102 citations)

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:

  • Four key questions about your purchasing controls program
  • Four mandatory steps your MDR procedures must address
  • Five activities to outline in your purchasing control system
  • Nine elements every CAPA investigation report must have
  • Ten points every process validation master plan must 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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