Quality & Technology 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 Study Presentations
- Trends in GMP Inspections by Overseas Regulatory Authorities and Examples of Findings (583KB)
(Osaka Venue) Mr. Masakazu Itakura, Chairperson, GMP Committee, Japan Active Pharmaceutical Ingredients Manufacturers Association
(Tokyo Venue) Mr. Takao Tsunematsu, Senior Manager, Quality & Technology Assurance Group, Specialty 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)
TAKEDA PHARMACEUTICAL COMPANY LIMITED Shigehiro HIGUCHI, Chief of Quality Assurance Audit Office