The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effe ...
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