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PMDA-ATC GMP Inspection Seminar 2018

with the support of PIC/S

Introduction

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.

Scope

Manufacturing process of APIs for Biologics

Key seminar objectives

The seminar is designed to address three key areas:

  1. Through group discussions on inspection planning of a mock inspection, participants will focus on abstraction of risks of each processes   and consider risk mitigation

- Understand key points that will have an impact to product quality
- Grope risk mitigation method

  1. Confirm site response and understand risk controlled manufacturing process

- Compare key points of risks that are abstracted at inspection planning and practical condition
- Understand the rationale behind discrepancy

  1. The method which site applied to accomplish Data Integrity

- Understand the gap of soft and hard
- Understand the site’s approach to increase level of security using systems

Who should apply

  • Inspectors from regulatory authorities at beginner or intermediate level; maximum 15 participants. If PMDA received more than 15 registration forms, eligible person will be selected.
  • The training will be provided in English (with simultaneous translation in some sessions). All participants are requested to actively take part in all of the discussions.

Date

November 26 to 30, 2018

Program (subject to change)

See attached for the draft program

Registration

Number of participants: approx. 15
Close of registration: September 14, 2018.

  • Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached).  Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
  • Early registration is recommended. Also, please be sure to allow enough time to obtain the visa for entry to Japan.
  • If the number of applications exceeds the capacity, the number of participants from each country may be limited.
  • Confirmation of the registration and additional information will be sent to the approved participants after the close of registration.

Fee

There is no registration fee for this Seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.

Location

Utsunomiya city, Tochigi prefecture, Japan
Visit the web site below for detailed travel guide of Tochigi prefecture.
https://travel.tochigiji.or.jp/

Contact us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp

Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan

(Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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