FDA News Invites President/CEO of InfoStrength to Discuss the Latest FDA Part 11 Guidance
Raleigh, NC - March 11, 2003 - Rita Geiger, President/CEO of InfoStrength, Inc. is the key note speaker for the FDA's audio-conference on "Part 11 Compliance: An Analysis of the FDA's Latest Action." Ms. Geiger will provide an analysis of the scope and intent of the agency's current thinking with regard to the use of electronic formats. She will also discuss the agency's stance on enforcing the underlying predicate rules and the new risk-based approach to good manufacturing practices.
The audio-conference will be hosted by FDAnews at 1:30 - 2:30 p.m. EST on Wednesday, March 19, 2003. For registrations, visit the FDAnews Website: http://www.fdanews.com/calendar/15853.html
M. Rita Geiger, CEO/President, InfoStrength, has over 13 years of business expertise in medical, industrial automation and information technology industries. She has more than 10 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.
About InfoStrength:
InfoStrength, Inc. is a proven leader of information management and regulatory-compliant business strategy and applications. A comprehensive blend of 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)TM 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
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