|
ValidationVaultTM Compliance Resource CD
Electronic Reference Library of
FDA Compliance Resources
New June 2011 Edition
EduQuest’s latest 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, the EU's new Annex 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.
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
|
|
EduQuest
Now Offers
2011 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 2011
FDA CFRs,
each volume current as of April 1,
2011
Each CFR volume
represents the most up-to-date print edition of the U. S. Food and
Drug Administration’s regulations.
Beginning in June 2011, the U.S. federal government will release the
individual CFR volumes every few weeks until all 9 volumes are
available by early fall 2011.
Place your
order now,
and your
CFRs will be shipped to you immediately as they become available.
Click below for a complete list of 2011 Title 21 CFR volumes,
prices, and ordering information.
|
