WASHINGTON DC, USA -- PHARMA UPDATE NEWS SERVICE™ -- NOVEMBER 9, 2006: The FDA is expected to issue a ruling by early 2007 requiring companies to do risk analysis as a component of electronic recordkeeping requirements. According to Martin Browning, a former FDA investigator, this development is "under the radar" and the industry is likely to be caught unaware of potentially billions of dollars in additional costs. This approach to information management goes beyond the original scope of Part 11, also expected to undergo revisions next year.

Take the necessary steps now to ensure your organization remains compliant.

The Third Annual FDA Information Management Summit, brought to you by FDAnews, is your opportunity to discover what 2007 holds for information assurance...right from the top. You'll hear straight from the FDA what the agency's new goals and expectations are, including an update from John Murray, member of the Part 11 Working Group, on the new draft 21 CFR Part 11 regulation.

At the Summit you'll experience the new "extended learning sessions," which allow in-depth exploration of each agenda topic, plus face-to-face interaction with speakers and colleagues.

See the entire agenda

In this skills-building summit, you'll discover:

• Best practices for information management 21 CFR Part 11 compliance
• Proactive approaches to compliance and enforcement, including response to Form 483s
• Insights on how technology is changing the face of clinical trials
• The top five concerns of manufacturing medical devices offshore
• How to best manage commercial off-the-shelf systems (COTS)
• Five strategies to ensure the future retrieval of e-records
• Tips for achieving a corporate culture that embraces e-clinical strategies and applications
• A "take-home" checklist of the best ideas to implement for business sustainability

Come a day early for our pre-conference workshop where you'll learn:

• A Good Systems Practice (GSP) approach to all your IT projects
• Tips to lower server management costs
• Compliance strategies for 21 CFR Part 11 and Section 211 software validation
• Best practices to consolidate existing servers and deploy new ones
• And much, much more!

• Martin Browning, President, co-founder, EduQuest, Hyattstown, MD
• Brian Fitzgerald, Deputy Director, Division of Software and Electronic Engineering, FDA, CDRH, Rockville, MD
• M. Rita Geiger, CEO/president, InfoStrength, Raleigh, NC (Chairperson)
• 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
• John Murray, Software Compliance Expert, FDA, CDRH, Rockville, MD
• Dennis Rubenacker, Senior Partner, co-founder, Noblitt & Rueland, Irvine, CA
• John Speakman, Manager, National Cancer Institute, Bethesda, MD
• Charlie Sodano, Manager, Information Services, Berlex, Richmond, CA
• Joseph Vinhais, Vice President, Regulatory Compliance, Brooks Software, Chelmsford, MA

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 also has many 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.

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.

• 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

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.

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