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InfoStrength and Greenwood CVR Training Bridges the FDA Part 11 Guidance Knowledge Gap
Raleigh, NC - October 27, 2003 - InfoStrength, Inc., a Raleigh based Information Technology Company, and Greenwood CVR, RTP's own full service regulatory consulting firm, will be hosting an innovative training series to assist life science professionals understand and cope with the new FDA Part 11 guidance.
Raleigh, NC - October 27, 2003 - InfoStrength, Inc., a Raleigh based Information Technology Company, and Greenwood CVR, RTP's own full service regulatory consulting firm, will be hosting an innovative training series to assist life science professionals understand and cope with the new FDA Part 11 guidance.
"There is a lot of confusion about what has changed and what has remained the same with the latest risk-based guidance for 21 CFR Part 11 from the FDA," said Rita Geiger, CEO and President of InfoStrength. "Our one day training session will clarify for life science professionals the scope and impact of current FDA thinking."
The InfoStrength/Greenwood CVR training series will be held in multiple locations throughout North Carolina beginning in Wilmington on November 3rd. Subsequent locations include RTP on November 4th, Winston-Salem on November 18th and Wilson on November 20th. The seminar will specifically clarify the scope, application, and impact of the FDA's new Part 11 guidance. The training will cover in detail what the new regulatory focus on risk assessment means for your operations and how you can proactively mitigate risk to your organization.
"The timeliness of the topic, the convenient venues, and the group discounts for training has created a great deal of interest in this training series," said Chris Wellington, Director of Greenwood CVR, who is hosting the training series. "We are excited about the opportunity to bring this needed training program not only to Raleigh but also to other North Carolina scientific communities such as Wilson and Wilmington. North Carolinian professionals rarely have the opportunity to attend this type of training in their own backyard."
Those wishing to register can contact Greenwood CVR at (919) 755-5861 or at http://www.greenwoodcvr.com/training.htm.
About InfoStrength
InfoStrength, Inc., a minority owned business headquartered in Raleigh, NC, 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 modular and highly configurable web based product, the InfoStrength Smart Enterprise Suite (SES), address FDA 21 CFR Part 11 and HIPAA requirements, is configurable to meet client's internal quality standards, and is designed to enable an entire enterprise and its partners to more effectively collaborate and more efficiently share knowledge in a secure environment. You can learn more about InfoStrength at www.infostrength.com.
About Greenwood
CVR Greenwood CVR, RTP's own full service regulatory consulting service, offers dedicated resource management expertise to deliver on-time solutions that support your core compliance needs. Regardless of the level of need, from executive level planning to hands on execution, Greenwood CVR is the solution. Greenwood CVR is a unique consortium comprised of an Expert Consulting Group and skilled Project Associates providing full services turnkey solutions in compliance, validation, and regulatory affairs. Whether your needs are for writing SOPs, training, validating new equipment, or handling 483's, Greenwood CVR can help. You can learn more about Greenwood CVR at www.greenwoodcvr.com.
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