Quality Committee GMP Case Study Group for 2011
Monday, September 12, Osaka Venue: Mielparque Osaka
Thursday, September 15, Tokyo Venue: Tower Hall Funabori
Program
Special Lecture
- Toward a Globally Acceptable GMP Inspection System - From the GMP Inspection System Research Study - (794KB)
(Osaka Venue) MHLW Research Group, Pharmaceutical Affairs Division, Department of Health and Medical Care, Osaka
(Tokyo Venue) MHLW Research Group, Quality Control Department, Pharmaceuticals and Medical Devices Agency, Japan Yasuhiro Kinoh
Case Presentations
- Trends in GMP Inspections by Overseas Regulatory Authorities and Examples of Findings (583KB)
(Osaka Venue) GMP Committee Member, Japan Active Pharmaceutical Ingredients Manufacturers Association (JAPMA)
(Tokyo Venue) GMP Committee Chairman, Japan Active Pharmaceutical Ingredients Manufacturers Association (JAPMA) Mr. Takao Tsunematsu, Senior Manager, Quality Assurance Group, Special Products, Tokuyama Corporation, Kashima Plant - Case Studies and Responses to GMP Inspections by the U.S. FDA and European QP (197KB)
Mr. Keizo Sakuta, Group Manager, Quality Assurance Department, Kaken Pharmaceutical Co.
- DSP Oita Plant's Response to Global Development - Preparation and Response to PAI by US FDA - (677KB)
Yoshihito Nozaki, Production Quality Assurance Department, Production Division, Dainippon Sumitomo Pharma Co.
- Quality/GMP System Initiatives for Globalization (1.1MB)
Mr. Shigehiro Higuchi, Chief, Quality Assurance Audit Office, Takeda Pharmaceutical Company Limited