Quality Committee GMP Case Study Group for FY2014
Tuesday, September 16, Tokyo: Tokyo Kyurian
Friday, September 19, Osaka: Mielparque Osaka
Program
Special Lecture
- The Latest Trends in ICH Quality - Focusing on Q3D (Guidelines for Elemental Impurities in Drugs) - (415KB)
Toshinori Azuma, Examination Specialist, New Drug Evaluation Department 3, Pharmaceuticals and Medical Devices Agency (PMDA)
Case Presentations
- 1. Key points of EU GDP revision and our case study (2.3MB)
Sanofi K.K. Masato Kawamoto, General Manager, Quality Assurance Department, Sanofi K.K.
Tetsuo Sugiyama, Pharmacist, East Japan Distribution Center (Tokyo venue)
Mayumi Sato, Pharmacist, West Japan Distribution Center (Osaka venue) - 2. Kissei's version of the Pharmaceutical Quality System (482KB)
Takumi Takeuchi, Quality Assurance Department, Kissei Pharmaceutical Co.
- 3. About our response to inspections by PIC/S member countries (1.2MB)
Tatsuya Fujii, Assistant Manager, Quality Control Section, Quality Control Department, Production Division, Otsuka Pharmaceutical Co.
- 4. PIC/S GMP as a GQP (725KB)
Naoki Shimizu, Group Manager, GMP Promotion Group, Quality Assurance Department, Reliability Assurance Division, Daiichi Sankyo Company, Limited