Organizational Change Management Best Practices for Systems Regulated by FDA

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Organizational Change Management Best Practices
for Systems Regulated by FDA
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Who can Benefit from this course
Information technology analysts project
managers organizational change managers
business process engineers QC/QA managers and
analysts clinical data managers and scientists
analytical chemists compliance managers
lab managers automation analysts computer
system validation specialists GxP training
specialists business stakeholders and
individuals who are responsible for computer
system validation planning execution, testing,
reporting, compliance, and audit. This webinar
will also benefit any consultants, contractors or
vendors providing products and services to the
life sciences industries and who are involved in
computer system implementation, validation and
compliance.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
3
Webinar Description
This course is intended to provide specific
guidelines for coaching attendees on the best
practices for creating organizational change as
it relates to computer systems regulated by FDA.
These include, but are not limited to system
implementation, testing, validation, migration,
integration, upgrade and retirement. Computer
system validation has been regulated by FDA for
more than 30 years, as it relates to systems used
in the manufacture, testing, distribution and
management of a product in the pharmaceutical,
biotechnology, medical device, animal health,
tobacco and other regulated industries.Organizat
ional change management is a key aspect of
computer system activities involving the FDA's
guidelines on the system development life cycle
(SDLC). As such, there are specific deliverables
and tasks that must be completed in accordance
with FDA requirements.There are best practices
associated with testing methodologies used in the
FDA-regulated arena, and these can be used to
develop a standard and consistent approach within
a company.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
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Why Should you Attend
The attendee will learn how to develop a standard
approach to managing organizational change when
users not only have to accept new processes,
workflows and systems, but have to do so in a
manner that complies with FDA guidelines for
computer systems. In some cases, users will be
new to the concept of validation and FDA
regulation, and will have to be coached on how to
follow the necessary procedures. This is true in
the Tobacco industry, where regulations are
emerging, but it is also true in pharmaceutical
and related industries where IT staffing may not
have the skills or training required. It's
important to look at what is going to change,
what are some of the threats and challenges, and
what methods you can use to mitigate
these.There is an enormous body of
documentation and information available that can
be overwhelming. This course will provide a
condensed overview of the practices that deliver
the best results by directing the attendees to
the most critical and cost-effective techniques
and tools available to assure compliance.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Objectives of the Webinar
The course will focus on the key aspects of
organizational change management, including best
practices and principles for handling this key
component of project work in an FDA-regulated
environment (i.e., the system "touches" product
during the manufacturing, testing or distribution
of the product, or during any other functional
activity). The material will include the various
aspects of change management, including planning,
execution, assessment and feedback. The result
will be a prescriptive approach to helping teams
and individuals reach a higher level of
acceptance to change.FDA guidelines are very
specific in terms of how computer systems are to
be managed, and each company should have a
specific strategy and methodology, along with a
set of rigorous tactical processes and procedures
that prescribe how organizational change should
be managed.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Instructor Profile
Carolyn Troiano IT/Business Leadership
Professional
Carolyn Troiano has more than 25 years of
experience in computer system validation in the
pharmaceutical, medical device, animal health and
other FDA-regulated industries. She is currently
the ERP (Enterprise Resource Planning) Program
Manager at the City of Richmond, VA, where she is
overseeing the implementation of a large, complex
system that spans more than 40 agencies and is
used by more than 4,000 City employees.Prior to
working for the City, Carolyn worked directly, or
on a consulting basis, for many of the larger
pharmaceutical companies in the US and Europe.
Carolyn was responsible for computer system
validation across all regulated functions at
Wyeth Laboratories, now part of Pfizer. She
developed validation programs and strategies back
in the mid-1980s, when the first FDA guidebook
was published on the subject. While at Wyeth,
Carolyn co-authored 21 CFR Part 11, or the FDAs
electronic record/electronic signature (ER/ES)
regulation as part of an FDA/Industry
partnership. She has taught ER/ES compliance,
along with computer system validation and risk
management/compliance at a number of Fortune 100
pharmaceutical, medical device and other
regulated firms. Her experience includes work
with laboratory automation systems (LAS),
laboratory information management systems (LIMS),
clinical data systems (CDS) and many other
FDA-regulated systems involved in the
manufacturing, testing and distribution of
pharmaceutical and biological products.During
her career, Carolyn worked with Merck as an
automation analyst and with Eli Lilly as Manager
of Computer System Validation for a new plant in
VA. She has also done consulting work at
Schering-Plough (now part of Merck), Novartis,
Lederle Labs, Glaxo-Smith-Kline, Johnson
Johnson, Bristol-Myer-Squibb, Forest Labs,
Aventis Behring and Aventis Pasteur, amongst many
other companies, large and small.Carolyn has
participated in industry conferences, providing
very creative and interactive presentations. She
is currently active in the Oracle User Group,
Association of Information Technology
Professionals (AITP), and Project Management
Institute (PMI) chapters in the Richmond, VA
area. Carolyn also volunteers for the PMIs
Educational Fund as a project management
instructor for non-profit organizations.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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About OnlineCompliancePanel
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Organizational Change Management Best Practices
for Systems Regulated by FDA
Register Here http//bit.ly/ChangeManagement_Best
Practices For more details please contact
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com