FDAnews Invites President/CEO of InfoStrength to Discuss Part 11 Risk Assessment Strategies

Rita Geiger, President/CEO of InfoStrength, Inc. is the key note speaker for the FDAs audio-conference on Effective Part 11 Risk Assessment Strategies for Electronic Records Compliance."

Raleigh, NC --(PRWEB) Sept. 4,2003--- September 6, 2003 -- Rita Geiger, President/CEO of InfoStrength, Inc. is the key note speaker for the FDAs audio-conference on Effective Part 11 Risk Assessment Strategies for Electronic Records Compliance."

Ms. Geiger will discuss practical ways to develop, implement and monitor effective risk assessment of electronic records. She will analyze the three essential elements of risk management: risk analysis, risk evaluation and risk control on product integrity and provide examples of the type of risks associated with systems that store electronic records and propose approaches to risk analysis. Ms. Geiger will also identify steps that incorporate risk assessment as part of the design lifecycle process to avoid overcompliance and reduce costs. Two effective risk management tools, failure mode and effects analysis and fault tree analysis, used to examine critical systems will be discussed through a case study.

The audio-conference will be hosted by FDAnews at 1:30 -- 2:30 p.m. EDT on Wednesday, September 17, 2003. For registrations, visit the FDAnews Website: http://www.fdanews.com/calendar/16806.html

M. Rita Geiger, CEO/ president, InfoStrength, has business expertise in medical, industrial automation and information technology industries. She has more than 13 years of regulatory, quality standards and operational procedures experience and has been a participant in numerous national and international committees to develop industry standards and requirements. Ms. Geiger holds a B.S. in electrical engineering with a focus in computer science from Brooklyn Polytechnic University and an M.B.A. from the Fuqua School of Business at Duke University.

About InfoStrength:

InfoStrength, Inc. is a proven leader of information management and regulatory-compliant business strategy and applications. A comprehensive blend of products and regulatory services combined with decades of IT, regulatory and quality expertise, and solid strategy formulation solve our clients' individual challenges, on time and within budget.

InfoStrength's configurable and modular software product, the InfoStrength Smart Enterprise Suite (SES) protects the intellectual property, creates collaboration among business resources and addresses document, project, and management challenges of the life science industry. Following an in-depth needs analysis, InfoStrength's applications meet FDA 21 CFR Part 11 and HIPAA requirements, comply with internal quality standards, and include a completely documented software lifecycle. For more information, visit the company's Web site at www.infostrength.com