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ValidationVaultTM Compliance Resource CD
Electronic Reference Library of
FDA Compliance Resources
New April 2010 Edition
EduQuest’s new ValidationVault Compliance Resource CD gives
you desktop access to a treasure-trove of FDA laws, regulations,
guidances, inspection protocols, warning letters, and international
guidelines – all impacting your validation activities and decisions.
The CD
has been assembled by EduQuest’s top validation experts –
including Martin Browning, co-author of FDA’s Part 11 rule –
specifically for those involved in computerized systems validation,
quality management, software development, or electronic
records/signatures compliance.
Included
in the ValidationVault Compliance Resource CD are the latest
versions of FDA’s Investigations Operation Manual (IOM),
relevant Title 21 CFR regulations, a complete library of FDA guidance
documents related to validation and Part 11, key ICH guidelines, and
much more.
ValidationVault
Compliance Resource CD
Table of Contents:
- Unabridged
text of laws enforced by FDA
- Unabridged
text of key regulations enforced by FDA – Title 21 CFR
- Library and
Chronology of FDA Guidance Documents related to computerized
systems, software, electronic records/signatures and other
automated systems
- FDA warning
letters related to automated systems used for GxP compliance
- International
Guidance Documents and guidelines (including PIC/S, GHTF, ICH,
and EudraLex)
- And much
more
Cost of
the ValidationVault Compliance Resource CD is $295, including
shipping and handling. The latest edition of the CD is available free
to all students who attend EduQuest’s “FDA Auditing of Computerized
Systems and Part 11” course held nationwide ( click here for upcoming course
schedule).
How
to Order:
1. Call EduQuest,
301-874-6031 (
Business hours,
9 a.m. – 5 p.m. Eastern Time) and charge your
investment to Visa, Master Card or American
Express:
2. Or mail
a check for $295 (U.S.) payable to
EduQuest to:
Compliance Library
EduQuest,
Inc.
1896 Urbana Pike, Suite 14
Hyattstown, MD 20871 USA
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EduQuest
Now Offers
2010 Title 21 CFRs
To provide a convenient and
reliable source for current Code of Federal Regulations (CFRs), EduQuest
has teamed with Bernan,
a leading distributor of publications for the U.S. government.
Order
the entire 9-volume set of title 21 CFRs, or you can order individual
CFR volumes. You also can order the following special
industry-specific sets:
·
5-Volume Drugs/Biologics Set
·
2-Volume Devices/Diagnostic Set
Place Your Order NOW for the New
2010
FDA CFRs.
Not all 2010 volumes are available yet - the federal government will
officially release individual CFR volumes one by one, any time from
May through August 2010, until all are available.
The government does NOT publish the volumes in order. For
example, the volume containing Parts 300-499 could possibly be
release months before the volume containing Parts 1-99.
Each volume, no matter when it is released, will be current through
April 1, 2010.
Placing your order NOW through EduQuest guarantees you Automatic Priority Shipment as soon as each new volume
becomes available. Your CFRs will be shipped to you within 48
hours of their official release by the federal government.
Be the first to receive your new 2010 CFR publications by ordering
below.
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