Quality Committee GMP Case Study Group for FY2015
Tuesday, September 15, Tokyo: Tokyo Kyurian
Friday, September 18, Osaka: Mielparque Osaka
Program
Special Lecture
- Trends in PIC/S and Current Status of GMP Investigations (891KB)
Dr. Kentaro Hara, Senior Specialist, Quality Control Department, Pharmaceuticals and Medical Devices Agency
- Temperature Risks and Countermeasures for Joint Delivery of Refrigerated Pharmaceuticals (720KB)
Dr. Tsuyoshi Namura, Managing Director, DP Network Co.
Case Presentations
- Examples of Quality Risk Management Initiatives at Manufacturing Sites (410KB)
Susumu Shinagawa, Manager, Pharmaceutical Quality Assurance Section, Pharmaceutical and Medical Quality Assurance Department, Toray Industries, Inc.
- Response to GMP inspections from PIC/S member countries (1.5MB)
Eiji Iba, Manager, Quality Assurance Section, Quality Assurance Group, Quality Operations Department (Nagoya), Pfizer Pharma Inc.
- Examples of PIC/S GMP Responses in Drug Formulation Plants and Active Pharmaceutical Ingredients Plants Ahead of FDA Inspections (1.7MB)
Yukihiko Dan, Section Chief, Tokushima Quality Control Section 1, Quality Control Department, Production Division, Taiho Pharmaceutical Co.