Migrating to 21 CFR Part 11 requirements has become a priority for many of the Food and Drug Administration FDA regulated companies. This is no longer a concept for many of them, but rather tangible guidelines to be implemented into daily processes. This paper contains information on the ruling, as...
In their ongoing quest to build a better mousetrap, software developers have combined calibration management with the latest business process developments to create an improved system for controlling calibration and maintaining measurement instrumentation. Quality standards such as ISO 9001, ISO/IEC 17025 and ISO/TS 16949; regulatory requirements such as the Food...
As pharmaceutical companies continue to expand both domestically and globally, Good Manufacturing practices GMP processes must be closely monitored as the FDA is pushing for standardization within these organizations. The manufacturing and QA processes that take place in one location need to be similar with those in other locations. In...
Food and Drug Administration FDA itself has been working with industry to support new technologies for safe and cost effective compliance. Two such initiatives are the electronic records and signature rule, 21 CFR Part 11, and a new program titled "Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach"....
While equipment maintenance and calibration have been a Food and Drug Administration FDA focus, equipment qualification has received increased scrutiny. This focus has been seen in QC and R&D labs. Many organizations have maintained calibration and maintenance programs, yet qualification programs are new for many companies. From a Good Manufacturing...
New Albany banker Mike Staten has been elected chair of the board of trustees for Blue Mountain College. Staten, senior vice president for BNA Bank, succeeds Ripley businessman Harold Wayne Hankins as head of the board that governs the 135-year-old Christian liberal arts college in North Mississippi. "It...
Creating the Land of the Sky: Tourism and Society in Western North Carolina. By Richard D. Starnes (Tuscaloosa: The University of Alabama Press, 2005. xiv plus 231 pp.). Each year about twenty million motorists drive along the Blue Ridge Parkway in the scenic mountains of Virginia and North...
Articles 2007-09-22
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