Quality Committee FY 2018 GMP Case Study Group
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 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.
- Initiatives Related to Data Integrity at the GMP Committee of the Pharmaceutical Manufacturers Association of Japan (2.6MB)
Data Integrity Project, GMP Subcommittee, Quality 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.
- Local Initiatives against Global Standards for Computerized System Validation (1.5MB)
Satoko Tanaka, Senior IT Quality Analyst, IT Quality, AstraZeneca K.K.