REGULATORY
”GMP Team” to Begin Mock GMP Inspections in Kinki Region from Next February
A “GMP Team” consisting of GMP inspectors from the seven prefectures of the Kinki bloc will conduct mock inspections and training starting next February. The team will visit a manufacturing facility in Hyogo Prefecture with the cooperation of a pharmaceutical…
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





