In June of 2015, National Institutes of Health (NIH) announced the closure of the sterile production unit of the Pharmaceutical Development Section (PDS) within the NIH Clinical Center in Bethesda, Maryland. During an inspection, the U.S. Food and Drug Administration (FDA) identified problems with facilities, equipment, procedures, and training protocols. To address the FDA’s findings, NIH has proposed establishing an Office of Research Support to improve and maintain compliance with research regulations and standards at the PDS.

In an effort to ensure that NIH senior management is getting the most rigorous and experienced guidance, NIH Director Francis S. Collins, M.D., Ph.D., created a new Advisory Committee to the Director (ACD) made up of volunteer healthcare industry leaders. The mission of the committee is to examine the structural and operational issues and make recommendations to improve the management, organization, and financing of the NIH Clinical Center.

The WorkingBuildings Group of Companies is pleased to announce that F. Kurt Last, President of our Clinical Products Division, was appointed to the committee. Mr. Last is WorkingBuildings’ Subject Matter Expert on engineering controls for current good manufacturing practices (CGMP). He will provide guidance to the ACD on GMP matters, as well as sterile compounding guidelines described in USP <797> and USP <800>.

Michael L. Weiss, President of The WorkingBuildings Group of Companies, said, “We are very honored to be recognized by the NIH. Kurt is one of the leading subject matter experts in the industry for engineering controls in research, manufacturing, and delivery of new targeted-cell and biologic programs. Rest assured that Kurt and the rest of the committee will help NIH maintain world-class standards and practices in their Clinical Center.”

For more information on NIH please refer to www.nih.gov

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