Quality & Technology Committee GMP Case Study Group for 2008
Japan Pharmaceutical Manufacturers Association Quality & Technology Committee Pharmaceutical Publication Center
Program
Special Lecture
- Recent Administration of Pharmaceutical Surveillance and Guidance (558KB)
(Tokyo Venue) Ms. Akiko Hayashi, Specialist, Supervisory Guidance and Drug Control Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
(Osaka Venue) Mr. Hidemoto Kazama, GMP Guidance Officer, Supervisory Guidance and Drug Control Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
- (Tokyo Venue) GMP Conformity Surveys, etc. for Pharmaceuticals Conducted by the Tokyo Metropolitan Government (302KB)
Mr. Natsumi Yoshino, Drug Surveillance Section 3, Pharmaceutical Surveillance and Guidance Division, Wide Area Surveillance Department, Health and Safety Research Center, Tokyo Metropolitan Government
- (Osaka Venue) Recent Pharmaceutical Administration - GMP Inspection in Yamaguchi Prefecture - (3.1MB)
Mr. Yoshiaki Kono, Chief, Pharmaceutical Guidance Team, Pharmaceutical Affairs Division, Health and Welfare Department, Yamaguchi Prefecture
Case Study Presentations
- Integration of Quality Risk Management and Quality System in Factories (243KB)
Chihiro Kao, General Manager, Quality Control Department, Takaoka Plant, Astellas Toyama Inc.
- The use of quality risk management (383KB)
Mr. Takashi Hasegawa, Manager, Planning & Operations Section, Pharmaceutical Production Department, Tokushima Plant 2, OTSUKA PHARMACEUTICAL Co.
- Quality Management System Initiatives (531KB)
Mr. Yoshinari Fukada, General Manager, Odawara Plant, DAIICHI SANKYO CO.
- Formulation Development and CTD Submission by Quality by Design - Our Case Study by FDA Pilot Program - (263KB)
Mr. Kimiya Okazaki, General Manager, CMC Pharmaceutical Science Department, Pfizer JAPAN INC.