Efficient Computer System Validation - 10 Easy Steps

Date:Tuesday, November 15, 2011
Time:10:00 AM PST | 01:00 PM EST
Live Webinar
Duration:75 Minutes
Efficient Computer System Validation - 10
Easy Steps
Price:$245.00

Overview: This webinar details all of the templates used to


Register Now
create validation documentation, usually saving two-thirds of
the time and costs.

InstructorProfile:
The 10-step risk-based approach to COTS software validation
minimized documentation and ensures efficient
David Nettleton
implementation of new and upgraded computer systems. This
FDA Compliance Specialist
experience will prepare you to perform a validation project.
David Nettleton, is an FDA
Compliance Specialist for 21 CFR Part
Areas Covered in the Session:
11, HIPAA, and Computer System
Validation. His latest book is "Risk
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Learn which documents the FDA expects to audit.
Based Software Validation - Ten
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How to use the risk-based validation approach to lower
easy Steps" that relates to the
costs.
development, purchase, installation,
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How to link requirements, specifications, risk
operation and maintenance of
management, and testing.
computerized systems used in
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Document a computer system validation project using
regulated applications. He
easy to understand fill-in-the-blank templates.
specializes in performing gap
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Based on: "Risk-Based Software Validation - Ten Easy
analysis, remediation plans, SOP
Steps" (Davis Horwood International and PDA -
development, vendor audits,
www.pda.org, 2006).
training, and project management.
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Step-by-step instructions for performing and
He has completed more than 185
documenting a risk assessment, and how to use the
mission critical software validation
results to reduce validation documentation.
projects. ...more
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Reduce testing by writing test cases that trace to


elements of risk management.
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Your Necessity is our Priority
Who Will Benefit:

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IT
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QA
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Q C
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Laboratory staff
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Managers
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GMP, GCP, GLP professionals
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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