with the support of
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC GMP Inspection Seminar 2018" for GMP inspectors from overseas regulatory authorities. This seminar is organized by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) with the support of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
This seminar will be held in Tochigi prefecture, Japan, from November 26 to 30, 2018.
The primal object of this seminar will be Risk-based Inspection and Data Integrity. We will offer practical training in the form of a mock inspection. Target participants will be GMP inspectors at beginner or intermediate level. This seminar will enable inspectors to conduct risk-based GMP inspection.
Participation from many regulatory authorities is welcomed.
Manufacturing process of APIs for Biologics
The seminar is designed to address three key areas:
- Understand key points that will have an impact to product quality
- Grope risk mitigation method
- Compare key points of risks that are abstracted at inspection planning and practical condition
- Understand the rationale behind discrepancy
- Understand the gap of soft and hard
- Understand the site’s approach to increase level of security using systems
November 26 to 30, 2018
See attached for the draft program
Number of participants: approx. 15
Close of registration: September 14, 2018.
There is no registration fee for this Seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
Utsunomiya city, Tochigi prefecture, Japan
Visit the web site below for detailed travel guide of Tochigi prefecture.
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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