Quality & Technology Committee GMP Case Study Sessions for FY2016
September 12 (Mon) Tokyo: Kyurian
Friday, September 16, Osaka: Mielparque Osaka
Program
Special Lecture
- The latest trend of PIC/S GMP and case studies pointed out by PMDA (3.3MB)
Japan Pharmaceuticals and Medical Devices Agency
Dr. Ryoko Naruse, Director, Pharmaceutical Quality Control Section, Quality Control Department (Tokyo venue)
Dr. Yoshiaki Hirono, GMP Expert, Quality Control Department (Osaka venue)
Case Study Presentations
- Issues and Case Studies on PIC/S GMP Annex 8 All Packages Confirmation Test (1.3MB)
Koji Kimura, GMP Planning Office, Astellas Pharma Tech, Inc.
- Examples of Shipping Risk Assessment and Validation Responses Toward GDP Enforcement and Future Challenges (1.5MB)
Dr. Taketoshi Numata, Quality Assurance Department, Quality Division, GlaxoSmithKline K.K.
- Latest Trends in Data Integrity and Our Approach (941KB)
Satoshi Sasaki, Associate Director, Quality and Compliance Division, Quality Control Department, MSD K.K.
- Response to GMP inspections by PIC/S member countries (3.3MB)
Michiko Sano, Quality Assurance Section, Quality Control Office, Fujiyama Plant, ONO PHARMACEUTICAL CO., LTD.
- Quality Risk Management Initiatives for Product Quality Verification, etc. (1.3MB)
Akio Miwa, Group Manager, Quality Control Department, TAISHO PHARMACEUTICAL CO., LTD.