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FAST SHIP- Mastering and Managing the FDA Maze : Medical Device Overview,Harnack

TextbooksXpress
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US $43.89
ApproximatelyAU $67.58
Condition:
Brand new
2 available1 sold
Other people bought this. 1 has already sold.
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US $3.99 (approx. AU $6.14) Economy Shipping.
Located in: Avenel, NJ, United States
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Estimated between Thu, 4 Sep and Wed, 10 Sep to 94104
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eBay item number:275764331989
Last updated on 26 Aug, 2025 00:33:31 AESTView all revisionsView all revisions

Item specifics

Condition
Brand new: A new, unread, unused book in perfect condition with no missing or damaged pages. See the ...
Binding
SOFTCOVER
International ISBN
9788174890436
Contents
SAME as in US edition
Packing
Shrinkwrapped- Box Packed
Product Type
INTERNATIONAL EDITION
If Order Expedited Shipping
DELIVERED WITHIN 5-7 DAYS BY DHL/UPS/FedEx/Aramex
Edition
2
ISBN
9780873898874

About this product

Product Identifiers

Publisher
Quality Press
ISBN-10
0873898877
ISBN-13
9780873898874
eBay Product ID (ePID)
204243823

Product Key Features

Publication Year
2014
Book Title
Mastering and Managing the FDA Maze : Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
Topic
Public Policy / Agriculture & Food Policy (See Also Social Science / Agriculture & Food), American Government / National
Language
English
Genre
Political Science
Author
Gordon Harnack
Format
Trade Paperback

Additional Product Features

LCCN
2014-015434
Dewey Edition
23
Dewey Decimal
344.7304/1
Synopsis
The number of FDA regulations and the agency's increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm's employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
LC Classification Number
KF3827.M4

Item description from the seller

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TextbooksXpress

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Average for the last 12 months
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4.9
Reasonable postage costs
4.9
Postage speed
4.9
Communication
4.9

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    Past year
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    I had a wonderful experience buying from this seller! They quickly replied to my messages, answering questions that I had on the books. The item description was exactly what I received. The seller also packaged the book set with bubble wrap to make sure there was no damage during shipment. The shipping was quick and I received the item 4 days early! 10/10 experience with this seller!
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    Past 6 months
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    they arrived quickly, sooner than i even expected! they were very nicely and thoroughly wrapped, and in excellent condition. they looked exactly as pictured in the photo and they’re worth the price, considering they’re typically more from big retailers! good, trustworthy seller!
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    Past 6 months
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    Got it 3 days earlier then expected. Great quality was wrapped very well. Great value for the money. All the books were in perfect condition. No rips or bends on the pages excellent. Highly recommend this seller.
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