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The FDA handed out 1,008 Form 483s to device manufacturers in 2015. Was your company one of them? If your company wasn’t, are you confident you can do as well next time?
With FDA inspections getting tougher every day you need to be well-versed in the regulations you must follow and the procedures the agency will use to conduct your inspection. Luckily for you there is a complete resource available to help you get that edge.
Medical Device Inspections Guide, 2016 Edition
This brand new edition gathers all the information you need in one resource, one that you will want to keep close at hand. You’ll receive all the regulations, guidances and policies that impact medical device inspections, including:
Tools FDA investigators use to train and prepare — Investigations Operations Manual, Compliance Program Guidance Manuals and Quality Systems Inspection Technique Manual
21 CFR 820 — Quality System Regulation and Preamble to Quality System Regulation
FDA guidances that lay out information on how inspections will be handled
Documents governing the third-party audit program
Published by FDAnews, this one-stop reference has been — and will continue to be — the go-to source for current FDA inspection guidelines for manufacturing processes.
And now, with the FDA’s continuing crackdown on inspections, this publication is more crucial than ever.
Order Your Copy Today
PDF Edition
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PDF Edition — $377
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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 FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
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Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
