Quality Committee GMP Case Study Group for 2009
September 14 (Mon) Tokyo venue: Tower Hall Funabori
Thursday, September 17, Osaka venue: Mielparque Osaka
Program
Special Lecture
- Recent Administration of Pharmaceutical Surveillance and Guidance (749KB)
(Tokyo Venue) Mr. Hirotada Nagai, Specialist in Pharmaceutical Affairs Information, Supervision, Guidance and Drug Control Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare
(Osaka Venue) Mr. Hiroyuki Itsumi, GMP Guidance Officer, Supervision, Guidance and Drug Control Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare - About the Pharmaceutical GMP Conformity Surveillance, etc. Conducted by the Tokyo Metropolitan Government (749KB)
(Tokyo Venue) Ms. Takae Kosuge, Chief, Pharmaceutical Surveillance Section 3, Pharmaceutical Surveillance and Guidance Division, Wide Area Surveillance Department, Health and Safety Research Center, Bureau of Social Welfare and Public Health, Tokyo Metropolitan Government
- Pharmaceutical Surveillance and Guidance in Osaka Prefecture (216KB)
(Osaka Venue) Ms. Namiko Sadatoku, Deputy Chief, Pharmaceutical Production Group, Pharmaceutical Affairs Division, Health and Medical Care Department, Osaka Prefectural Government
Case Presentations
- CAPA (Corrective and Preventive Action) Management and Examples of Initiatives for its Control (441KB)
GlaxoSmithKline K.K.
(Tokyo Venue) Mr. Toshiaki Maeda, General Quality Assurance Department
(Osaka Venue) Mr. Jun Ichido, General Manager, General Quality Assurance Department - Examples of Initiatives in Corrective and Preventive Action Systems (661KB)
Mr. Yasuhiko Fukushima, Manager, Quality Assurance Section, Quality Assurance Department, Banyu Pharmaceutical Co.
- CAPA Systems and Education and Training (2.3MB)
Noritaka Seko, General Manager, Quality Control Department, Boehringer Ingelheim Pharmaceuticals, Inc.