Quality Committee GMP Case Study in 2012
Tuesday, September 18, Tokyo Venue: Tower Hall Funabori
September 21 (Fri.) Osaka venue: Mielparque Osaka
Program
Special Lecture
- Current Global GMP Status and Trends with Focus on EU & PIC/S
Pharma Medicines Technical Operations Global Quality & Compliance,
F. Hoffmann-La Roche Ltd
Dr.-Ing. Stephan Rönninger
Case Presentations
- 1. Raw Material Supplier Management - Approach to Risk Management Type Audit Methodology - (460KB)
Mr. Katsuhiko Sawada, Manager, Quality Assurance Department, Kowa Company, Ltd.
- 2. Case studies of GMP inspections by the U.S. FDA and European EMA (436KB)
Yasuhito Koyama, Deputy General Manager, Quality Assurance Department Shionogi & Co.
- 3. ICH Q9 Quality Risk Management and Case Studies of EMA Inspections (1.9MB)
Mr. Toshitaka Imamura, General Manager, GMP Promotion Department, Toyama Technology Center, Astellas Pharma Tech, Inc.