What's New?
QSI Launches Sales & Support
Office in Colorado
As Quality
Systems Integrators (QSI)
continues to increase
its national presence,
we have established a
Colorado office to
expand and strengthen
our sales and support
services.
We are happy to
introduce the team of
Lenisse and Tim Lippert
who will support QSI's
corporate office in
Pennsylvania, by
providing comprehensive
sales and consulting
services for our TMS
products. Both Lenisse
and Tim will be
beneficial and valuable
assets to the QSI team.
Welcome aboard!
Lenisse Lippert, MBA
"I
am very excited about my new
venture with QSI, this
transition feels like a natural
fit. I have implemented their
TMS software in several
companies and through these
experiences have found QSI to
have a wonderful work ethic with
excellent customer service. I
am proud to be supporting a
company with these values and am
looking forward to my
contribution to the new services
being offered by QSI."
Timothy R.
Lippert, MBA
"I am
proud to become a member of
the QSI team. I am looking
forward to "growing" into
the job I have taken on and
in gaining new
responsibilities as the
opportunities arise. I find
this new endeavor to be both
challenging and exciting. I
look forward to the many new
relationships I will
gain and in keeping up with
the technological
advancements of this
industry."
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Upcoming
Events
FREE Lunch & Learn
Westminster, Colorado
September 5, 2008
QSI is sponsoring a
FREE Lunch & Learn
to discuss
Implementation of a Part
11 Compliant Electronic Document
Management System. This
event will be held on September
5th, from 12:15 to 1:30 MST, at
Front Range Community College
Library (Meeting Room L-211),
Westminster, Colorado. To
reserve your space or for more
information, please click the
above link or call QSI at
800-458-0539.
(Are you interested in having
Quality Systems
Integrators sponsor a Free
Lunch & Learn in
your city? Please
email
your request or call our office
at 800-458-0539.)
Regulatory Affairs
Professionals Society
Hynes Convention Center, Boston,
Massachusetts
September 15 & 16, 2008
QSI will
be exhibiting at the RAPS Annual
Conference & Exhibition on
September 15th and 16th. The
Regulatory Affairs Professionals
Society (RAPS) is the leading
worldwide member organization
devoted to the health product
regulatory profession. Please
stop by and visit QSI at
Booth # 331.
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Quality Quote
"Quality is about passion and
pride."
by
Peters and Austin |
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QbD Biotech Pilot Program
 The
Food and Drug
Administration is seeking volunteers from
pharmaceutical companies to participate in a
pilot program involving the submission of
quality (chemistry, manufacturing, and
controls) information for biotechnology
products in an Expanded Change Protocol,
consistent with the principles of
quality-by-design (QbD) and risk management
in pharmaceutical manufacturing.
The purpose of the pilot program is to
gain more information on and facilitate
agency review of quality-by-design,
risk-based approaches for manufacturing
biotechnology products. The pilot will
focus on products reviewed by the FDA's
Office of Biotechnology Products, which
operates in the Office of Pharmaceutical
Science at the Center for Drug
Evaluation and Research.
This pilot program will assist FDA in
developing guidance for industry on
quality-by-design and risk management in
pharmaceutical manufacturing.
Requests to participate in the pilot
program are due by September 30, 2009.
More information is available at
www.fda.gov.
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