By Christine Park, Quality Architech
We all know that establishing or changing the culture within an organization is very difficult and requires strong leadership skills from the entire executive management team. As the QA manager or QA staff, you will need to influence the executive management commitment to provide strong quality culture. As the quality assurance manager, it is critical that you understand these expectations, as well as the role and responsibilities of the executive management team.
By Michael Gotz, QuickSTAT One of the more challenging aspects of shipping biological commodities of all types is the regulatory requirement to determine whether or not there are infectious pathogens present and to classify the shipment for transport purposes. The following discussion is designed to present a clear and coherent set of guidelines for classifying biological commodities in compliance with the regulations.
By Uwe Kirschner, Siemens Industry, Inc. Process analytical technology is a system for designing, analyzing, and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality. The main idea is to become more efficient, while reducing over-processing, enhancing efficiency, and minimizing waste.