Quality Committee GMP Case Study Sessions for FY 2019
Monday, September 9, Osaka: Mielparque Osaka
September 13 (Fri) Tokyo: Kyurian
Program
Special Lecture
- Recent Guidance Cases and Regulatory Trends (2.4MB)
Independent Administrative Institution Pharmaceuticals and Medical Devices Agency
Toshitaka Nakamura, Investigation Specialist, Investigation Division, Kansai Branch (concurrently in charge of Pharmaceutical Quality Control Department) (at Osaka venue)
Masashi Takahashi, Investigation Specialist, Pharmaceutical Quality Control Division, Pharmaceutical Quality Control Department (at Tokyo venue)
Case Presentations
- Tsumura's Approach to Fostering Quality Culture (2.5MB)
Takashi Sekine, General Manager, Quality Assurance Division, Tsumura Corporation
- Chugai's Aimed Quality Assurance Strategy (4.7MB)
Yukihiko Kimura, General Manager, Quality Assurance Unit, Chugai Pharmaceutical Co.
- Data Integrity (DI) Initiatives at Mitsubishi Tanabe Pharma Corporation (1.9MB)
Hiroshi Fujisaki, General Manager, Quality Assurance Department, Yoshitomi Plant, Mitsubishi Tanabe Pharma Corporation