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You
Are Invited!
To join us...
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Session 1: |
Friday, May 2,
2008 |
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Time: |
1:00 pm
(Eastern) /
11:00 am (Mountain)
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Cost: |
Early Bird:
$199.00
(Deadline 4/25/08)
Standard: $249.00 |
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Session 2: |
Tuesday, May 20,
2008 |
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Time: |
1:00 pm
(Eastern) /
11:00 am (Mountain)
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Cost: |
Early Bird:
$199.00
(Deadline
4/25/08)
Standard: $249.00 |
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Registration
information below |
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Featured Speaker |
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Cumulative of 22 years
experience in various industries
including information and
business solutions in the areas
of legal, risk management,
corporate, biotechnology
regulatory/medical device
regulatory and quality
functions.
Ms. Lippert managed an 8-month
project for a 150K electronic
document management system with
positive company wide impact and
a return on investment of 500K
over a three year period; drove
the project to completion on
time and within budget. During
this project Ms. Lippert was
responsible for all aspects of
implementation for 21 CFR Part
11 including defining user
requirements, risk assessment,
validation activities,
validation master plan writing,
change control, and all SOPs
associated with the project.
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Sponsored by |
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Quality Systems
Integrators
P.O. Box 91
Eagle, PA 19480
610-458-0539
Work
Smarter... Not Harder
Visit Sponsor |
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Webinar Event
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Current Industry
Thinking for Part
11 Compliance
The
biotech, pharmaceutical, and
medical device industries are
becoming more dependent on
computerized systems for all
aspects of product lifecycle.
Clinical trials are managed
using software as they capture
patient information. Regulatory
submissions are being submitted
electronically. Laboratory
assays on drug efficacy are
being performed using
computerized instrumentation.
All of these systems fall
under 21 CFR Part 11
regulation.
This 1-hour
presentation will focus
on current industry thinking;
overview of the background,
scope of the regulation; how the
regulation applies to industry,
where the regulation stands in
approval process; and current
findings by the FDA on the
regulation.
Topics covered will include:
QUESTIONS?
FOR MORE INFORMATION ABOUT THIS
WEBINAR PLEASE
E-MAIL
OR CALL QUALITY SYSTEMS INTEGRATORS
AT 610-458-0539. |
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How
To Register:
Please
click the link below for the WEBINAR
REGISTRATION FORM. Registration
will not be processed without
payment information.
Registration information can
be e-mailed, faxed or phoned to:
Renee
Cabrey
Quality Systems Integrators
Phone: 610-458-0539
Fax: 610-458-7555
You will
receive an e-mail confirmation with
instructions for attending the
Webinar.
We look
forward to welcoming you to this
educational Webinar.
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Webinar Registration Form |
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