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REGISTER
HERE
Please
RSVP to
Lunch choices
will be e-mailed to interested
parties (box lunch or designer
salads will be prepared by Udi's
Catering).
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FEATURED SPEAKER
Lenisse Lippert, MBA
Lenisse Lippert
has 18 years of experience with
biotechnology and medical device
industries. Recent consulting
experience includes managing
implementation of several
electronic document management
systems (EDMS). Implementation
for Part 11 compliant projects
includes completion of a return
on investment for approval of
the project; building a project
plan; writing and running
validation scripts; training
personnel; and writing documents
such as validation master plan,
user requirements, risk
analysis, change control,
problem reporting, workstation
configuration, and disaster
recovery.
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EVENT SPONSOR
Quality Systems
Integrators
Work Smarter... Not
Harder
Visit Our Sponsor
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Topic:
Implementation of a Part
11 Compliant Electronic
Document Management
System
Date: Friday,
September 5th, 2008
Time:
12:15 pm - 1:30 pm MST
Location:
Front Range Community
College Library Meeting
Room L-211
3645 West 112th
Avenue
Westminster, CO
80031
(see directions
below)
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This session presents
key principles,
objectives, and
introduces techniques
that are necessary to
successfully implement
an Electronic Document
Management System.
Including:
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Discussion around
the principles of
electronic document
management
implementation
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Understand and explain
the return on investment
(ROI)
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Develop
appropriate project plan
including getting user
buy-in
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Understand where to get
regulatory guidance
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Set up
validation package to
include appropriate
components
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Maintain ongoing
compliance
For
more information, call
800-458-0539
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THIS PRESENTATION IS NOT
PRODUCT SPECIFIC BUT GIVES
YOU TOOLS TO RESEARCH AND
FIND THE BEST SOFTWARE
SOLUTION FOR YOUR COMPANY
BASED ON YOUR DEFINED USER
REQUIREMENTS. |
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DIRECTIONS
From Denver
Take I-25 to Hwy 36
toward Boulder
Take Hwy 36 to Sheridan
Blvd, exit north
Stay on Sheridan to
112th Avenue, turn east
Go ½ mile and Front
Range Community College
will be on your left
Turn left into the first
street into the parking
lot and enter the
building at the main
entrance.
Take a left, go through
the Library and Room
L-211 is on your left.
[For further directions,
call 303-404-5539]
From Boulder
South on Highway 36 to
104th Avenue (Church
Ranch Blvd) exit
East on 104th Avenue one
mile to Sheridan Blvd
North on Sheridan Blvd
to 112th Avenue
East on 112th
Avenue, go .5 mile -
Front Range will be
on your left.
Turn left into the
first street into
the parking lot and
enter the building
at the main
entrance.
Take a left, go
through the Library
and Room L-211 is on
your left. [For
further directions,
call 303-404-5539]
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