Quality & Technology Committee GMP Case Study Group 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 Study Presentations
- Daiichi Sankyo Group's Response to the Revised GMP Ministerial Ordinance (2.2MB)
Mr. Haruhiro Takenoshita, Quality Assurance Department, DAIICHI SANKYO CO.
- Data Integrity (DI) Initiatives at Takeda Pharmaceutical Company Limited (2.3MB)
Mr. Dai Yamashita, Quality Assurance Department, Quality Assurance Division, TAKEDA PHARMACEUTICAL COMPANY LIMITED
- JPMA GMP Subcommittee's Efforts for Quality Culture (545KB)
Mr. Hiroshi Fujie, Quality Culture Project, GMP Subcommittee, Quality & Technology Committee, Japan Pharmaceutical Manufacturers Association, CHUGAI PHARMACEUTICAL CO., LTD.
- Biopharmaceutics Classification System (BCS) based BioWeber - Explanation of the Guideline and Issues in Japan - (3.3MB)
Mr. Yutaka Takahashi, ICH Quality Group, Quality & Technology Committee, Japan Pharmaceutical Manufacturers Association, Astellas Pharma Inc.