Quality Committee GMP Case Study Sessions for FY2020
Program
Special Lecture
- Recent Guidance Cases and Regulatory Trends (1.3MB)
Dr. Tsuneki Akazawa, Pharmaceutical Quality Control Division, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (concurrently with Research Division, Kansai Branch), Japan Pharmaceuticals and Medical Devices Agency
Case Presentations
- Daiichi Sankyo Group's Response to the Revised GMP Ordinance (2.2MB)
Mr. Haruhiro Takenoshita, Quality Assurance Department, Daiichi Sankyo Espha Co.
- Data Integrity (DI) Initiatives at Takeda Pharmaceutical Company Limited (2.3MB)
Mr. Haruhiro Takenoshita, Quality Assurance Department, Daiichi Sankyo Espha Co.
- Quality Culture in the GMP Committee of the Pharmaceutical Manufacturers Association of Japan (545KB)
Mr. Hiroshi Fujie, Quality Culture Project, GMP Subcommittee, Quality Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
- Biopharmaceutics Classification System (BCS) based BioWeber - Guideline Explanation and Issues in Japan - (3.3MB)
Mr. Yutaka Takahashi, ICH Quality Group, Quality Committee, Japan Pharmaceutical Manufacturers Association (JPMA)