[CinSUG] Upcoming Seminars
- From: "Jeff Ahrnsen" <jeff@xxxxxxxxxxx>
- To: <cinsug@xxxxxxxxxxxxx>
- Date: Thu, 23 Sep 2004 12:52:46 -0400
Hello Everyone,
Something that we felt might be of interest to a number of you:
"SEC Associates, Inc., a regulatory compliance consulting firm, is
partnering
with the SAS Institute to offer training on a simple, risk-based approach to
computer system compliance for organizations involved with pharmaceutical
and biotechnology clinical trials. This seminar presents a practical
methodology
for assessing computer systems to determine the appropriate level of
validation
effort and what controls, if any, are appropriate to assure the integrity of
your data. This methodology applies to all computer systems, not just SAS
programs. Because of the emphasis currently being placed on the predicate
rules, the seminar includes the pharmaceutical clinical trial regulations
and how the regulations apply to computer systems. The course is designed
to
provide information and tools that can be used immediately in your
organization
or modified to fit internal policies and procedures. The course is
appropriate
for clinical project managers, CRAs, data management, QA, computer system
validation groups, IT, statistical programmers, and even clinical site staff
involved with EDC systems.
This seminar will be offered in Chicago on November 2-3, 2004. The seminar
is also being offered in a number of other locations around the country.
Additional information and dates of the seminars can be found at
http://support.sas.com/training/us/crs/bracc.html.";
Regards,
Jeff Ahrnsen
CinSUG
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