Date:Tuesday, November 15, 2011
Time:10:00 AM PST | 01:00 PM EST
Efficient Computer System Validation - 10
Overview: This webinar details all of the templates used to
create validation documentation, usually saving two-thirds of
the time and costs.
The 10-step risk-based approach to COTS software validation
minimized documentation and ensures efficient
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
Learn which documents the FDA expects to audit.
Based Software Validation - Ten
How to use the risk-based validation approach to lower
easy Steps" that relates to the
development, purchase, installation,
How to link requirements, specifications, risk
operation and maintenance of
management, and testing.
computerized systems used in
Document a computer system validation project using
regulated applications. He
easy to understand fill-in-the-blank templates.
specializes in performing gap
Based on: "Risk-Based Software Validation - Ten Easy
analysis, remediation plans, SOP
Steps" (Davis Horwood International and PDA -
development, vendor audits,
training, and project management.
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.
Reduce testing by writing test cases that trace to
elements of risk management.
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Who Will Benefit:
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.
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