Third Annual FDA Information Management Summit - Nov. 29 - Dec. 1, 2006

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Third Annual
FDA Information Management Summit
Information Assurance: The New Path to Competitive Advantage
Nov. 29 - Dec. 1, 2006 - Bethesda North Marriott Hotel and Conference Center, North Bethesda
The FDA is expected to issue a revised 21 CFR Part 11 regulation by the end of 2006, which will cause drug and device companies to carefully review their current approaches to information management. Changes will need to be made and billions of dollars of investment
in compliance efforts may be at stake.
At the Third Annual FDA Information Management Summit you will?
Hear from top FDA officials and industry experts on what the future holds for information management, including an update on the new draft 21 CFR Part 11 regulation
Explore the FDA?s new goals and expectations for information management in 2007 with:
Best practices and processes for information management and 21 CFR Part 11 compliance
Steps for a proactive approach to compliance and enforcement, including how to respond to Form 483s
How to manage commercial off-the-shelf systems, including techniques to improve validation strategies
Get real-world strategies from industry leaders, including:
Five strategies to ensure the future retrieval of e-records
Tips for achieving a corporate culture that embraces e-clinical strategies and applications in clinical trials
A ?take-home? checklist of the best ideas to implement for business sustainability
Choose between concurrent sessions to customize your learning experience
Attend the pre-conference workshop for expert in-depth guidance on how to reap significant cost savings through server consolidation
And much, much more.
Featured Speakers:
Carolyn Apperson-Hansen, Research Associate, Cleveland Clinic Foundation, Cleveland, OH
Martin Browning, President, Co-Founder, EduQuest, Hyattstown, MD
Brad Cooper, Senior Vice President, Product Strategy, Co-founder, Plateau Systems, Arlington, VA
Brian Fitzgerald, Deputy Director, Division of Software and Electronic Engineering, FDA, CDRH, Rockville, MD
Steve Frampton, Program Office Manager, Information Technology, 3M, St. Paul, MN
M. Rita Geiger, President/CEO, InfoStrength, Raleigh, NC
Wells Horton, Systems Manager, Procter & Gamble Pharmaceuticals, Norwich, NY
John Jordan, Manager, Clinical Database Services, Schering-Plough, Kenilworth, NJ
Russ King, Vice President, Business Development, InfoStrength, Raleigh, NC
Mark Licata, President, Bio-Track, Richmond, VA
Stuart Merdian, Global Information Operations Leader, 21 CFR Part 11 Leader, sanofi-aventis, Kansas City, MO
Alan Minsk, Partner, Leader Food and Drug Practice Team, Arnall Golden Gregory, Atlanta, GA
John Murray, Software Compliance Expert, FDA, CDRH, Rockville, MD
Keith Parent, CEO, Court Square Data Group, Springfield, MA
Gordon Richman, Vice President, Strategic Consulting and General Counsel, EduQuest, Hyattstown, MD
Dennis Rubenacker, Senior Partner, Co-founder, Noblitt & Rueland, Irvine, CA
Charlie Sodano, Manager, Information Services, Berlex, Richmond, CA
John Speakman, Manager, National Cancer Institute, Bethesda, MD
Joseph Vinhais, Vice President, Regulatory Compliance, Brooks Software, Chelmsford, MA
100% Satisfaction Guarantee
Your satisfaction is 100% guaranteed ? money back or credit. If you?re not satisfied with the quality of this program, let us know in writing and we?ll refund your registration fee or credit your tuition toward another FDAnews learning event.

Who Will Benefit
Regulatory affairs professionals
IT management
QA/QC managers and staff
Validation specialists
Clinical trial data managers
Laboratory information management
Software development personnel
Internal and external communications officers
Corporate legal affairs professionals
About the Conference Chairperson
M. Rita Geiger, CEO/President and co-founder of InfoStrength, has over 14 years of business expertise in life science, industrial automation and information technology industries. She has over 13 years of regulatory, quality standards and operational procedures experience. Rita was one of the initial members that defined and launched the first US program to evaluate safety critical software applications used in commercial and medical devices for Underwriters Laboratories. She has been a participant in numerous national and international committees to develop industry standards and requirements. She remains an active participant of industry associations where she continues to share her knowledge and experience to develop industry guidance. Rita holds a BS in Electrical Engineering with a focus in Computer Science from Polytechnic University and an MBA from The Fuqua School of Business at Duke University.
Team Discounts
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.
Conference Details
Date: Nov. 29 ? Dec. 1, 2006
Hotel: Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
Toll free (800) 859-8003
Tel: +1 (301) 822-9200
www.bethesdanorthmarriott.com
Room rate: $204 single or double (plus 12% tax)
Hotel reservation cutoff date: Nov. 15, 2006
Tuition

Regular Fee

Complete Passport
$1,990.00

Conference Only
$1,695.00

Pre-Conference Workshop
$595.00

Register Today!
Complete Conference and Workshop Passport: $1,990
Tuition includes the preconference workshop, all conference sessions, conference and workshop written materials, two breakfasts, one luncheon, one reception, refreshments and certificates of attendance for the workshop and conference.
Conference Sessions Only: $1,695
Tuition includes all conference presentations, conference written materials, two breakfasts, one luncheon, one reception, refreshments and a conference certificate of attendance.
Preconference Workshop Only: $595
Tuition includes the preconference workshop, workshop written materials, refreshments and a workshop certificate of attendance.
Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
Cancellations/Substitutions
Written cancellations received at least one week prior to the start date of the event will receive a 100% refund or credit toward a future FDAnews event. After that time, refunds will be subject to a $200 administration fee. Substitutions may be made at any time. No shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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