Quality Committee GMP Case Study Group for FY2021

Program

Special Lecture

Explanation of the operation of the revised GMP Ministerial Ordinance and the new system established by the revision of the Pharmaceutical Affairs Law (4.0MB)
Emiko Hirayama, Quality Control Section 1, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA)

Case Presentations

Electronic Manufacturing at Kaken Pharmaceutical's Shizuoka Plant (5.2MB)
Takuya Fujisawa, Kaken Pharmaceutical Co.
Example of Remote Inspection at Dainippon Sumitomo Pharma (1.8MB)
Mr. Koji Koyama, Dainippon Sumitomo Pharma Co.
Example of inspection of a medical institution regarding raw material cells for autologous cell products (2.7MB)
Mr. Tatsuhiro Mori, Novartis Pharma K.K.