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.

1. Contact Us: 416-915-4458
We Empower, You Comply!
To register for this webinar please visit https://compliancetrainings.com/siteengine/Login.aspx
Webinar Description:
Webinar On User Acceptance Testing
Product Id FDB1252
Category Food, Drugs & Biologics
Scheduled On Thursday, July 24, 2014 at 13:00 Hrs
Duration 60 Minutes
Speaker Jane Tucker
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.

2. 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
Speaker Profile:
To know more visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1252
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.
Who will benefit
Clinical Research Professionals
Data Managers
Statisticians
CRA's
Monitors
Anyone who interfaces with a validated clinical system