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Drug and Device Answerbook
This handy directory provides names, title, phone and address for ALL key contacts in CBER, CDER, CDRH, and FDA field offices. SPECIAL PRICING on this 2009-10 book!
In Stock
Price: $97.00
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Guide to Systems-Based Inspections (2008 edition)
Get all FDA guidance on systems-based audits of drug manufacturers. An important compliance tool to prevent 483s. Learn how to apply Quality Systems to the drug manufacturing world. SELLING OUT OF THESE QUICKLY. Please place your order today!
Note: If you are a NEW subscriber to INSPECTION MONITOR, this book is FREE. Please visit www.FDAInfo.com and click on "Subscriptions" to learn more.
In Stock
Price: $179.00
Retail: $349.00
You Save: $170.00
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Guide to Systems-based Inspections (2nd edition)
SELLING OUT -- 2007 Guide to Systems-based Inspections. Now only $69 plus shipping. These will NOT last long. Get the guide that will help drug and biologics makers fathom the new era of Quality Systems in drug manufacturing and compliance.
In Stock
Price: $69.00
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Guide to Vigilance and Adverse Event Reporting (2008 edition)
BIG DISCOUNT -- Clearing out the remainder of our Guide to Vigilance and Adverse Event Reporting. This handy books contains ALL FDA, ICH and EU guidelines to help manufacturers report drug and biologic adverse events. It includes the FDA Amendments Act of 2007 information, including guidance on doing risk-evaluation management strategies and FDA's latest initiative with the Centers for Medicare and Medicaid Services on drug safety reporting.
Note: This book is FREE if you subscribe to the unlimited license of Adverse Event Reporting News, our bi-weekly vigilance publication. To subscribe, please email us at Support@FDAINFO.com or call (800) 776-5105.
In Stock
Price: $249.00
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Part 11 Manual
This brand-new manual will be shipped this fall, at the price of $395, but we are selling pre-orders for $295 -- a savings of 25% (until Nov. 1 and then the full price is in effect). Shipping applied upon sale.
In Stock
Price: $295.00
Retail: $395.00
You Save: $100.00
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QS/Design Controls Guide
All applicable guidelines and assistance for medical device Quality Systems compliance on one big book.
In Stock
Price: $75.00
Retail: $149.00
You Save: $74.00
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