Quality & Technology Committee FY 2017 GMP Case Study Sessions
Friday, September 1, Osaka: Mielparque Osaka
Tuesday, September 5, Tokyo: Kyurian
Program
Special Lecture
- Case Studies on PIC/S GMP, Data Integrity and PQS (1.8MB)
Pharmaceuticals and Medical Devices Agency
Specialist: Hiroyuki Kawakita (Osaka Venue)
Quality Control Department Senior Specialist: Kentaro Hara (Tokyo Venue)
Case Study Presentations
- Case Study on Data Integrity Initiatives at BMS Aichi Plant (1.6MB)
Noboru Sugiura, Manager, Quality Assurance, Quality Operation, Aichi Plant, Bristol-Myers Squibb K. K.
- Case Study of our GDP Compliance in anticipation of the introduction of PIC/S GDP in Japan (1.1MB)
Takumi Matsunaga, Manager, Quality System Promotion Group, Quality Assurance Department, Quality Assurance Unit, CHUGAI PHARMACEUTICAL CO., LTD.
- Establishment of Pharmaceutical Quality System and Management Review (465KB)
Yoshikiyo Tanaka, General Manager, Pharmaceutical Quality Assurance Department, Quality Assurance Management Division, NIPPON SHINYAKU Co., Ltd.
- Fostering a Quality Culture through Human Resource Development (1.8MB)
Sachiko YAMAMOTO, Quality Assurance Manager, Compliance & Quality Management Department, NIPPON BOEHRINGER INGELHEIM CO., LTD.