Quality Committee GMP Case Study in 2013
Tuesday, September 17, Tokyo: Tokyo Kyurian
Friday, September 20, Osaka: Mielparque Osaka
Program
Special Lecture
- Management Strategies and Recent Trends Based on ICH Q8, Q9, Q10, Q11 (2.2MB)
Yoshihiro Matsuda, Acting Director, Drug Standards Division, Standards and Criteria Department, Pharmaceuticals and Medical Devices Agency (PMDA)
- Future Direction of Process Validation/Continuous Process Verification (2MB)
Quality Control Department, Pharmaceuticals and Medical Devices Agency
(Tokyo Venue) Kentaro Hara, Investigation Specialist
(Osaka Venue) Katsuhito Ohno, Investigation Specialist
Case Presentations
- About our PQS introduction case study (460KB)
Tetsuhito Takada, Deputy General Manager, Quality Assurance Office, Reliability Assurance Division, Mochida Pharmaceutical Co.
- Case Study of GDP Introduction and Response to Globalization (436KB)
Takumi Matsunaga, Manager, Planning & Promotion Group, Quality Assurance Department, Quality Assurance Unit, Chugai Pharmaceutical Co.
- FDA Inspection Response Experience (1.9MB)
Katsuji Matsumoto, General Manager, Corporate Quality Assurance Department, Quality Assurance Division, Quality Assurance Unit, Mitsubishi Tanabe Pharma Corporation