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Seminars & Events
Lecture titled "QA's new role and organization. Coworking with CDMO."
Exhibit at CPHI Japan 2025, April 9-112025/02/03

[Update] 25/04/14
Exhibition report and thanks for visiting

We exhibited at the “CPHI Japan 2025 (International Pharmaceutical Development Exhibition)” exhibition held at Tokyo Big Sight from Wednesday, April 9th ​​to Friday, April 11th, 2013.

A large number of customers visited the exhibition, and the exhibition was a great success. We thank all the customers who visited our booth and listened to our lectures. Thank you very much.

   

 

We hope that the contents of the exhibition at this exhibition will help solve the problems you are facing. If you have any opinions or questions, please get in touch with us.

 


 

CM Plus, as an official partner, will exhibit at CPHI Japan 2025, to be held at Tokyo Big Sight (Tokyo, Japan) from April 9 (Wed) to 11 (Fri), 2025. Our senior consultant, Ryoichi Tanaka, will make a lecture featuring QA’s role and organization. See more detail below.

Lecture (No English translation)

April 11 (Friday), 2025 15:30~16:15QA’s new role and organization. Coworking with CDMO.

In August 2021, the number of requirements increased due to Japan’s revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs.

We live in an era where QA work must be dramatically improved in quality and quantity.

As the production of new formulations, such as biopharmaceuticals, increases, QA’s role, and organization become more important, as they work closely with CDMOs, ensure quality throughout the lifecycle, and make continuous improvements.

This lecture talks about the current QA system in Japan, including recent examples.

令和3年8月、日本のGMP省令改正に伴う要求事項の増加により、QA業務は飛躍的に質・量ともに求められる時代がやってきている。バイオ医薬品などの新しい分野の製剤の製造が増える中、QAを中心にいかに製造業者として適宜CDMOなどと適切に連携し、ライフサイクルを通じた品質確保や継続的な改善等を行う必要がある。昨今の事例も交えながら現在求めらるQAの体制について解説する。

SpeakerCM Plus Corporation
Consulting Services Division
Senior Consultant
Ryoichi Tanaka

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Exhibition outline

Booth:4Y-04
Category : Bio Pharma

Exhibition CPHI Japan 2025
Date and Time April 9 (Wed) – 11 (Fri), 2025
10:00 ~ 17:00
Location Tokyo Big Sight

CPHI site