Jason Ni，Principal Engineer, Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd.

Topic: Cleanroom Environmental Monitoring and Risk Control

 Speaker Bio

Jason Ni has over 23 years of engineering and equipment management experience in a will-known foreign pharmaceutical manufacturing company. He not only has rich practical experience in equipment maintenance, management, selection and material selection of different systems and working conditions, but also has rich accumulation for new engineering projects. He has served many well-known foreign pharmaceutical manufacturing companies, mainly for oral solid preparations and biological preparations. He has participated in and led the new construction and validation of several projects, and was familiar with the stringent requirements of EU GMP and CFDA for plant facilities. He has led URS (ROOM BOOK) of plant facilities and equipment, made communication with Design Institute, technical disclosure, on-site quality control, progress control, system (equipment) commissioning, drafting, revision and implementation of verification documents. At the same time, he has rich accumulation of key and difficult points in the certification process and operation and maintenance. With deep understanding and cognition, the project delivery and system (equipment) optimization and improvement work have not been delayed for many projects, and the production has been smoothly delivered with almost zero defects. 

Presentation Summary

Base on the concept of QbD, the speech will be sharing the characteristics of how to use clean air conditioning systems in actual production activities to avoid control risks in the production environment by comparing the domestic and ISO requirements for the production environment of pharmaceutical manufacturing companies, as well as the monitoring methods of cleanliness requirements at different levels. And the speech will also be with the analysis of actual cases and solutions, help the audience understand how to make the clean air-conditioning system meet the environmental requirements of the GMP production process