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Surviving an FDA Inspection

April 2013
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The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips.

If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!

Order Today

Nothing can prepare you for an inspection better than Surviving an FDA Inspection. Published by FDAnews, this crucial publication is an easy reference to FDA inspection procedures for drug manufacturers.

Here you’ll find the very manuals and guidelines the FDA uses to train and direct its inspectors, covering such issues as:

  • Pre-approval inspections
  • Post-approval audits
  • Sterile drug process inspections
  • Drug repackagers and relabelers
  • API process inspection
  • Foreign manufacturers
  • Validation of cleaning processes
  • Sterile drug products made by asceptic processing
  • High purity water systems
  • Microbiological pharmaceutical quality control labs
  • Pharmaceutical quality control labs
  • Oral solid dosage forms — pre/post approval issues
  • Oral solutions and suspensions
  • Topical drug products
  • … and more

Get a look into the future

In addition to all of these valuable resource documents, Surviving an FDA Inspection includes an overview of the FDA inspection process, the agency’s objectives and manufacturing systems it focuses on, and valuable advice on how to create an inspection preparation system that will ensure you’ll be ready to face the FDA with confidence when it comes knocking on your door.

Order now and you’ll have an entire reference library of FDA inspection guidance for your manufacturing facility at your fingertips. You won’t find a better guide for getting your manufacturing facility up to speed and equipped to stand up under FDA scrutiny.

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Surviving an FDA Inspection is available in print or PDF for $397 each.

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