Quality Committee GMP Case Study Meeting for FY2023

Program

Special Lecture

PMDA's Efforts to Ensure Quality and Recent Guidance Cases

Pharmaceuticals and Medical Devices Agency
Quality Control Division 2, Pharmaceutical Quality Control Department
Mr. Shiro Kawahara, Senior Specialist

Case Presentations

GMP English Education in the Quality Assurance Department <Mochida's Approach> (Japanese only)

Mochida Pharmaceutical Co.
Mr. Yutaka Sasakura

Reliability Assurance in Approval Applications Using Master File (MF)

EA Pharma K.K.
Ms. Atsuko Okubo

Roles Expected of a Marketing Authorization Holder (GQP) in Globalization - Ensuring Approval Form Compliance and Japanese Quality

Takeda Pharmaceutical Company Limited
Mr. Hideki Ito

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Quality Committee GMP Case Study Meeting for FY2023

Program

Special Lecture

Case Presentations

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