Webinar On User Acceptance Testing

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Webinar On User Acceptance Testing
Product Id
FDB1252
Category
Food, Drugs Biologics
Scheduled On
Thursday, July 24, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Jane Tucker

To register for this webinar please visit
https//compliancetrainings.com/siteengine/Login.a
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• Webinar Description

Current regulations expect that all users are
appropriately trained and that must include being
trained how to effectively perform UAT. This
course provides an understanding of the role of
users in system validation and covers good
documentation practice and the writing of UAT
scripts. It then moves on to running UAT scripts
and the need for accurate reporting their results
plus the implications when a stage in a UAT
script fails and program changes are
necessary. ICH GCP and 21 CFR Part 11 both
expect that all computerized systems in clinical
research should be validated, and the
implementation of such computerized systems is
growing exponentially. The process of
establishing a computerized system is dependent
upon one pivotal role the User. The role of
the User especially with regard to the User
Acceptance Testing (UAT) is essential, but if
users are not trained in all the areas that they
need to be aware of when performing UAT the final
system when implemented may not be as effective
as it could have been.

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Area Covered In The Session

• Regulatory background
• The validation process and where users fit in
• The importance of documentation
• User Acceptance Testing (UAT)
• Writing UAT Scripts
• Running UAT Scripts

Who will benefit

• Clinical Research Professionals
• Data Managers
• Statisticians
• CRA's
• Monitors
• Anyone who interfaces with a validated clinical
  system

Speaker Profile
Over the past 28 years Jane has moved from
routine data cleaning activities, via computer
system validation onto training and data quality
activities, eventually specializing in Quality
Risk Management. Jane has worked for a variety of
large pharmaceutical companies and CROs before
retiring from GlaxoSmithKline. Jane now operates
as a Risk Management Trainer and Consultant,
specializing in Study Level Risk Management and
Risk Based Monitoring as well as facilitation of
risk assessment workshops.
To know more visit https//compliancetrainings.
com/SiteEngine/ProductDetailView.aspx?idFDB1252