FDA Extends CRADA with EduNeering for Inspection Training
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.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
