FDA Extends CRADA with EduNeering for Inspection Training

July 27, 2006
BioPharm International Editors

EduNeering (Princeton, NJ, www.eduneering.com) and the Food and Drug Administration (Washington, DC, www.fda.gov) have extended their existing Cooperative Research and Developing Agreement (CRADA), originally formed in 1999, for five more years.

EduNeering (Princeton, NJ, www.eduneering.com) and the Food and Drug Administration (Washington, DC, www.fda.gov) have extended their existing Cooperative Research and Developing Agreement (CRADA), originally formed in 1999, for five more years. The original agreement was the first such CRADA formed between FDA and a private sector company. EduNeering’s ComplianceWire technology developed the Office of Regulatory Affairs’ virtual university (ORA U) to help train local, state, and federal regulators in a variety of subjects, including inspections, using course material supplied by the agency. The extension will expand learning solutions available for FDA employees and clients through new technologies developed since the original agreement was formed, including a virtual audit, which will allow users to “walk-through” their facilities and identify any potential problem areas or possible violations.

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