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The Hollis Group, Inc.
Conference and Lecture Schedule
43rd DIA Annual Meeting
June 17 - 21, 2007
Atlanta, GA
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IT Track Session:
"Deploying Life Science IT
Using IEEE Methods"
Session Chair:
Thomas Quinn, President
The Hollis Group, Inc.
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Session Details:
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Session Title:
Deploying Life Science IT
Using IEEE Methods
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Track:
Information Technology (IT)
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Day & Time:
June 20, 10:30AM - 12:00PM
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Level:
ADVANCED
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Session Description:
This session presents an overview of IEEE-based prototyping methods, descriptions of case studies (i.e., bespoke code, COTS projects), change control and configuration management of code and documentation from development through test, concluding with labor, schedule, and cost performance summaries.
Objective:
Compare IEEE Systems and Software Engineering (S&SE) methods to currently used IT project methods; Estimate quality, schedule, and cost improvements as a result of migrating to IEEE-based methods; Justify an evaluation program to pilot IEEE methods on an IT project (COTS or bespoke code) in a life-science organization;
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Presentation(s) &
Speaker(s):
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Managing Code Changes during Testing
Barbara L Meserve
Director, Validation
AccuLogix, Inc.
United States
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Coordinating Document, System, and Infrastructure Changes
Michael S. Tarle
Senior Computer Validation Specialist
Nektar Therapeutics
United States
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Update on the Utah Medical Case
Daniel G. Jarcho
Attorney
McKenna Long & Aldridge LLP
United States
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Recently Completed Appearances:
IT Infrastructure Qualification Summit
A Proactive Approach to
Compliance and Infrastructure
September 26 - 27, 2006,
Atlanta, GA
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Pre-Conference Workshop:
"Integrating Infrastructure and
Systems Verification, Validation,
and Qualification"
Presented by:
Thomas Quinn, President
The Hollis Group, Inc.
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ABSTRACT:
The fundamental motivation for infrastructure qualification is that the infrastructure must support and enable the confidentiality, integrity, and availability of the information systems built on it. This workshop will describe methods to extend a development methodology to include concurrent systems and infrastructure Verification, Validation, and Qualification. Specific topics include:
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Establishing IEEE-based definitions for
Verification, Validation, and Qualification
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Extending the IEEE systems lifecycle
to include infrastructure
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Integrating infrastructure and system elements
into Configured and Qualified Arrangements
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Migrating legacy systems onto the qualified
Computer and Network Infrastructure (CNI)
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Throughout the workshop, Mr.
Quinn will encourage questions and discussions regarding deployment costs and schedules,
quality metrics, and overall improvements in efficiencies and compliance.
He will also devote considerable time to discussing how the IEEE-based
approach crosses regulatory domains and achieves a "Compliance Common
Denominator™"
that is acceptable to various inspectors, auditors, agencies, sponsors, and
customers.
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42nd DIA Annual Meeting
June 18-22, 2006
Philadelphia, PA
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IT Track Session:
"Deploying Life Science
IT Using IEEE Methods"
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The complete session,
including audio recording is available from:
LEARNING OBJECTIVES:
| 1.) Design a management-level IT deployment plan using IEEE Systems & Software Engineering (S&SE) terminology, project methods, and quality controls.
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2.) Compare IEEE S&SE methods to their existing IT project methods, and estimate probable quality, schedule, and cost improvements as a result of migrating to newer methods.
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Session
Details:
Speaker Name:
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Thomas Quinn
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Title:
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President
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Affiliation:
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The Hollis Group, Inc.
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Presentation Title:
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Session Chair
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Speaker Name:
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Amer Malik
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Title:
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Associate Director, IT
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Affiliation:
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Family Health International
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Presentation
Title:
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"Using ISO 17799
For Compliance"
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Speaker Name:
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Tamara G. Woodrum
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Title:
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Senior Director, IT Quality
and Compliance
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Affiliation:
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Nektar Therapeutics
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Presentation
Title:
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"Impact of the Utah
Medical Decision on IT Methodologies"
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Speaker Name:
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Barbara L. Meserve
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Title:
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VP, Quality Services
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Affiliation:
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AccuLogix, Inc.
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Presentation
Title:
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"Building a
Paperless Clinical Supply System Using IEEE Methods"
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The Center for Business Intelligence Presents:
3rd Annual Limiting Exposure to Liability in Clinical Trials
Dec 6 - 7, 2005
Philadelphia, PA
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In-Depth, Interactive Discussion,
Tuesday, 06 DEC, 2005
"Deploy a Clinical System for Risk Management."
Thomas Quinn, President,
The Hollis Group, Inc
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Watch this space for: âââ
If you'd like to have someone from The Hollis Group,
Inc. lecture for your audience, contact:
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The Multi-Agency Compliance Model:
Achieving Risk Reduction Using
Good Engineering Practice
"Auditing Computer and Network Infrastructures for Regulatory Compliance"
"e-Archiving - A 30-Year Total Cost of
Ownership (TCO) Model"
"Implementing C3Q™
at a CRO - A Case Study From Concept Through Audit"
"Deploying Compliant COTS Systems Using
Iterative Accretive Prototyping™ "
Server Qualification using C3Q™
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