Pmda - Pharmaceuticals and Medical Devices Agency

Events and Symposia

Report of the PMDA-ATC GMP Inspection Webinar 2022

PMDA-ATC GMP Inspection Webinar 2022

PMDA held a webinar entitled “PMDA-ATC GMP Inspeciton Webinar 2022“ with the support of Pharmaceutical Inspection Co-operation Scheme (PIC/S) on October 25 and 26.  This webinar was designed for officials of overseas regulatory agencies involved in GMP Inspection of pharmaceuticals.   Twenty-five inspectors/regulators from Botswana, Brazil, Ethiopia, Ghana,  India, Indonesia, Lao PDR, Malaysia, Myanmar, Pakistan, Peru, the Philippines, Saudi Arabia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia and Uganda joined the webinar.

The webinar opened with remarks by Mr. UZU Shinobu, Director of PMDA-ATC and by Mr. Paul Gustafson, Chairperson of PIC/S. The subsequent lectures were provided with the special lecture from PIC/S on Data Integrity (DI) followed by lectures on introducing risk-based data intergrity inspection and deficiencies at GMP inspection in Japan.  Then, participants made presentations on the current status of DI in their home countries/regions.  On the second day, case studies were conducted in group work on the theme of GMP inspection from the DI perspective.  Participants were able to engage in an in-depth and active Q&A session and interactive opinion exchanges by sharing their own experiences and issues. (see program for details)

At the end of the seminar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate to each participant virtually with congratulatory words.  Opening and closing sessions were moderated by Mr. ENO Hideo, Senior coordinator of the webinar.

Photos and participant comments

<Opening & Closing>



Comments from the participants:
"The webinar was properly organized, focused on the topic and provided many examples."
"The material and discussion are beneficiary to give wider view regarding inspection conducted in other countries. "
“The training material is very beneficial to conduct GMP inspection.”
“Group assignment and case studies given were very good. Had an interactive and brainstorming session.”
"The webinar was great overall. The time for breakout room is short though. But still, we had a great time."