Learn how computer system validation can be applied to mobile applications subject to FDA regulations, what are the best practices, trends in validation.

1. Applying Computer System Validation to
Mobile Applications
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2. Instructor Profile
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Carolyn Troiano has more than
30 years of experience in computer system
validation in the pharmaceutical, medical
device, animal health and other FDA-
regulated industries. She is currently
managing a large, complex data migration,
analytics and reporting program at a major
financial institution.
During her career, Carolyn worked directly, or
as a consultant, for many top-tier
pharmaceutical companies in the US and
Europe. She was responsible for computer
system validation across all GxP functions at a
major pharmaceutical company.

3. Description
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This webinar will discuss how computer system
validation can be applied to mobile applications
subject to FDA regulations. This is critical in order
to develop the appropriate validation strategy and
achieve the thoroughness required to prove that a
system does what it purports to do. It also ensures
that a system is maintained in a validated state
throughout its entire life cycle, from conception
through retirement.

4. Why should Attend
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You should attend this webinar if you
are responsible for planning, executing or managing the
implementation of any mobile application that is part of
a system governed by FDA regulations, or if you are
maintaining or supporting such a system. This course
will provide a condensed overview of the key practices
that deliver the best results by directing the attendees
to the most critical and cost-effective methods,
techniques and tools available.

5. Objectives
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 Upon completion of this session, attendees will have an
understanding of how to apply the concepts of computer system
validation to mobile applications, and develop a sound strategy for
meeting FDA compliance.
 The attendees will understand the level of effort required for
executing each phase of the SDLC, and the appropriate level of
documentation that must be completed to support it. They will also
gain an understanding of the training and skills required when
validating or maintaining mobile applications
 The attendees will have a good grasp of how to leverage these
practices across all systems by creating a standardized program for
applying the SDLC to mobile applications in accordance with FDA
requirements
.
.

6. Who can Benefit
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Information technology
analysts, QC/QA managers and analysts,
clinical data managers and scientists,
analytical chemists, compliance
managers, lab managers, automation
analysts, computer system validation
specialists, GMP training specialists,
business stakeholders and individuals
who are responsible for computer
system validation (specifically mobile
application) planning, execution,
reporting, compliance, maintenance and
audit.

7. How this Webinar Works
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 Username and Password will be sent to you
24 hours prior to the webinar
 Presentation handouts in pdf format will be
mailed to you
 Login to the session using the username and
password provided to you
 Get answer to your queries through
interactive Q&A sessions via chat
Track this link :
FDA Validation

8. Connect with Us
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Online Compliance Panel