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When FDA investigator Catherine J Laufmann arrives for an inspection, she brings a detailed, regulation-driven approach that focuses on critical components of your Quality Management System (QMS). Known for her rigorous evaluation of medical device m...

FDA Inspector Michael A. Charles focuses on five major areas during pharmaceutical inspections: cleaning validation, process control, lab testing, microbiological control, and training. His observations reveal recurring compliance gaps that could lea...

Your wellness app is a success. But the data is starting to tell a much bigger story. A story that whispers the difference between encouraging wellness and actively intervening in a user's health. This is the moment your company faces a critical pivo...

Recientemente me he encontrado un escenario donde se ha revertido la configuración de FDA. Una vez elminamos la configuración de FDA de las tablas afectadas procedemos a eliminar el fichero y el tablespace, pero no encontramos que el borrado, a pesar...
