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Report of the PMDA-ATC GMP Inspection Webinar 2021

PMDA-ATC GMP Inspecction Webinar 2021 

On November 25 and 26, 2021, PMDA held a webinar entitled “PMDA-ATC GMP Inspeciton Webinar 2021“.   This webinar was intended for officials of overseas regulatory agencies involved in GMP Inspection of pharmaceuticals.   A total of 29 regulators from Azerbaijan, Australia, Bangladesh, Ethiopia, Hong Kong, India, Indonesia, Libya, Malaysia, Moldova, Myanmar, Pakistan, Philippines, Saudi Arabia, Sri Lanka, Taiwan, Tunisia, Ukraine and Viet Nam, joined the webinar.

The webinar live session opened with remarks by Mr. UZU Shinobu, Director of PMDA-ATC followed by Mr. ENO Hideo, Director -Office of Manufacturing Quality for Drug at PMDA and the video message from Dr. Kevin O’Donnell, Chairperson of the PIC/S Working Group on QRM.

The first day of the webinar was a lecture on GMP regulations and recent topics in Japan, followed by a comprehensive discussion with participants introducing GMP systems and related issues in their own countries. The second day was a lecture on basic concepts and recent topics in Quality Risk Management (QRM), followed by two case studies on QRM. Participants were able to deepen their understanding of the recent developments in GMP regulations by sharing their own experiences and engaging in an in-depth and active question and answer session.

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, and Dr. Sato Junko, Director -Office of International Program of PMDA closed the webinar by the recorded video message.

< Program > see the attachment.

Photos and Comments




"This seminar provided a great opportunity to learn not only the regulation on GMP inspection in Japan but also any other countries"

"It's a good opportunity to attend this webinar and got more knowledge about GMP inspection. But you can arrange the time, I would love to know more information about QRM."

"The webinar is very timely and informative. The atmosphere was also very conducive, and despite the limitations of a virtual workshop the PMDA was able to handle it excellently to provide a noteworthy learning experience. "

“Japan's GMP regulation is excellent. I have to learn more about GMP from Japan. I am very pleased to attend this type of webinar.”

“The topic for Remote inspection is very useful and thank you for sharing”

 “I have learned about risk management in pharmaceuticals from this lecture. I can apply this knowledge in our country.”

 

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