On May 13, 2023, Mr. Ralf Gengenbach, founder and CEO of gempex, will share a speech " Modern Qualification & Validation as a prerequisite for EU market authorization" in the 4th QbD Quality Science Biologics Summit. In addition, gempex China booth number at this summit is B09. Welcome to visit and get free consultation service!

1. The Lecturer intro.

Ralf Gengenbach

With over 30 years of experience in the field of GMP compliance, Mr. Ralf has overall responsibility for the management of global consulting projects. He has rich technical experience in the field of life sciences and is familiar with biotechnology, sterile products, chemicals, APIS, etc.

At present, Mr. Ralf still provide domestic and foreign GMP solutions for the enterprises, including EU, US FDA, PIC/S, NAMP, TGA and WHO GMP compliance guidance. So far, he has helped hundreds of enterprises in the field of life science to implement the advanced GMP concept, and successfully passed the official inspection certification.

2. Lecture information

Lecture Topic:" Modern Qualification & Validation as a prerequisite for EU market authorization"

Lecture Content:

• Ÿ   A paradigm change in GMP – old versus new GMP requirements
• Ÿ   Process understanding – the meaning of CMAs, CQAs, CPPs
• Ÿ   What is modern Qualification and Validation – the authorities main focus
• Ÿ   How equipment suppliers to involve in modern qualification – a key success factor
• Ÿ   The ECA new guideline on modern qualification and validation

Lecture Time:2:40-3:15 p.m., May 13, 2023

Location:the Regulation Forum IV, Crowne Plaza Youtang, Chaoyang District, Beijing

In addition, gempex China will be at booth B09 of Zone B and prepare a lot of gifts. Welcome you to visit and get free consultation on site!

If you have any questions, please contact us byinfo-cn@gempex.com.

Click here to learn more about the 4th QbD Quality Science Biologics Summit.