Quality Committee GMP Case Study Workshop in FY2025
Program
Special Lecture
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PMDA's Efforts to Ensure Quality and Recent Guidance Cases
Pharmaceuticals and Medical Devices Agency
Quality Control Division 2, Pharmaceutical Quality Control Department
Associate Specialist (Quality Control), Quality Control Division 2, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA)
Mr. Takasane Ishii
Case Presentations
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Response to internalization of drug formulation process by reusing existing building
Asuka Pharmaceutical Co.
Quality System Section, Quality Assurance Department, Iwaki Plant, Production Division
Quality System Section, Quality Assurance Department, Iwaki Plant, Production Division -
Efforts to Implement a Data Governance System to Strengthen DI
Otsuka Pharmaceutical Co.
Quality Planning Office, Reliability Assurance Division
Mr. Tatsuya Fujii, Manager -
Introduction of the activities of the Quality Culture Project in the GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) - Building mutual trust in contract manufacturing
Mr. Hiroshi Fujie, Manager, Quality Assurance Department
, Chugai Pharmaceutical Co.