Quality Committee GMP Case Study Group for 2010
Monday, September 6, Tokyo Venue: Tower Hall Funabori
Thursday, September 9, Osaka venue: Mielparque Osaka
Program
Special Lecture
- About PIC/S (377KB)
GlaxoSmithKline K.K. President's direct reports Biologicals
(GMP Subcommittee of the Quality Committee of the Pharmaceutical Manufacturers Association of Japan) Dear Mr. Toshiaki Maeda -
Globalisation of GMP field PIC/S's role and expectation
Deputy Director, Inspectorate and Companies Department,The French Health Products Safety Agency (AFSSAPS)
(Former President of PIC/S) Mr. Jacques Morenas
Case Presentations
- Case Study on GMP Compliance in Europe and the U.S. at Eisai Kawashima Kouen (Kawashima Plant) (182KB)
Mr. Moriji Kajiura, Manager, Corporate QA Department, Quality Assurance Division, Eisai Co.
- Response to GMP Inspections by Overseas Regulatory Authorities and Initiatives to Address Findings (629KB)
Mr. Yasuhiro Sanobe, Deputy General Manager, Quality Control Group, Pharmaceutical Quality Assurance Department, Meiji Seika Kaisha, Ltd.
- Supplier Management using Global Database at Sanofi-Aventis (815KB)
Sanofi-Aventis K.K.
(Tokyo Venue) Mr. Goichi Yokoyama, Manager, Quality Assurance Department, Quality Assurance Unit
(Osaka Venue) Mr. Kazushi Mori, General Manager, External Quality Assurance Department, Quality Assurance Division