• Add this page to "Favorite pages"
  • Print Text
Here begins the text.

PMDA-ATC GMP Inspection Seminar 2016

with the support of PIC/S logo

Introduction

  The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the PMDA-ATC GMP Inpsection Seminar 2016. This Seminar is organized by PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) with the support of PIC/S.
  This "PMDA-ATC GMP Inspection Seminar 2016" will be a five-day seminar for GMP inspectors from regulatory authorities, held in Toyama prefecture, Japan.
  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.
 

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 20 participants.
  • If PMDA received more than 20 registration forms, eligible person will be selected

          The training will be provided in English (with consecutive translation in some sessions).
          All participants are expected to actively participate in all of the sessions.

Date / Time

     December 5 - 9, 2016.

Program (subject to change)

     See attached for detailed agenda (updated as of October 8, 2016)

     December 5, 2016 at Toyama Prefectural Civic Centre
        9:30-10:00          Registration
       10:00-17:00         Lectures (Risk-based inspection, Data integrity)
     December 6, 2016 at manufacturing site* in Toyama prefecture
        9:00-17:00          Inspection Planning
     December 7, 2016 at manufacturing site* in Toyama prefecture
        9:00-17:00          Mock Inspection
     December 8, 2016 at manufacturing site* in Toyama prefecture
        9:00-17:00          Mock Inspection
     December 9, 2016 at manufacturing site* in Toyama prefecture
        9:00-12:00          Summary and Present Observations
   *:  by cooperation of JPMA (Japan Pharmaceutical Manufacturers Association)

Registration  *Registration has closed*

  • Registration request should be made by filling in all the necessary items on the application form and sending it by e-mail to PMDA-ATC@pmda.go.jp
  • Registration will close on October 14, 2016.
  • Early registration is recommended. The registration may close before the deadline depending on the number of application. Also, please be sure to allow enough time to obtain the visa for enry 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 meeting 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

The Seminar will be held at Toyama City, Toyama prefecture.
Visit this site for detailed information on traveling to Toyama prefecture.
http://www.pref.toyama.jp/english/get_to.html

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

JCN 3010005007409

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

Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.