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Quality Issues Cause Loss of License to Operate
A global manufacturer with a history of merger and acquisition activities experienced significant quality issues resulting in loss of license at one of its major facilities. A key aspect of the company's remediation plan was a focused program centered on upgrading GMP knowledge via a mix of mandatory and voluntary training. The company modified and used UL's pharmaceutical content of more than 200 regulatory courses in a program that was mapped to individual job function in departments including QA, QC, Engineering, Manufacturing, Distribution, Sales, and Management.
Less than six months after program implementation, mandated GMP training was received and tested by 97 percent of the facility's employees, compared to only 25 percent prior to program implementation. Additionally, the company uses UL's technology to link third party content in a seamless system for the dissemination and tracking of critical business materials.
The initial deployment involved two global locations, including the corporate headquarters. Based on the success of that program, the company has expanded the program, with necessary translation and country-specific regulatory modifications, to two of its manufacturing operations in Europe.
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