Quality & Technology Committee FY 2018 GMP Case Study Sessions
September 10 (Mon) Tokyo: Kyurian
Friday, September 14, Osaka: Mielparque Osaka
Program
Special Lecture
- Proposed Revision of GMP Ministerial Ordinance and Examples of PMDA Inspections and Future Direction (2.7MB)
Japan Pharmaceuticals and Medical Devices Agency
Quality Control Department Senior Specialist: Hitomi Honma (Tokyo Venue)
Quality Control Department Investigation Specialist: Asaki Masuyama (Osaka Venue)
Case Study Presentations
- Hokkaido Joint Distribution Center Concept and Temperature Mapping (OQ and PQ) Result Report (1.6MB)
Keiko Sato, Manager, Quality Assurance Department, Astellas Pharma Inc.
- JPMA GMP Subcommittee's Initiatives Related to Data Integrity (2.6MB)
Data Integrity Project, GMP Subcommittee, Quality & Technology Committee, Japan Pharmaceutical Manufacturers Association
Satoshi Sasaki (Tokyo Venue)
Kazuhiro Okochi (Osaka Venue) - Report on the response to the Russian inspection (2.4MB)
Eiji Okada, General Manager, Kawashima Quality Assurance Department, Japan Regional Quality Control Division, Global Quality Headquarters, Eisai Co., Ltd.
- Local Initiatives against Global Standards for Computerized System Validation (1.5MB)
Satoko Tanaka, Senior IT Quality Analyst, IT Quality, AstraZeneca K.K.