15 years working experiences in pharmaceutical industry;
over 6 years working experiences in validation & GMP consult;
Clean room CQ expert;
With enough engineering projects validation management experiences;
Be familiar with pharmaceutical C&Q.
Published several professional technical articles about facility, validation, QMS, etc.
Serviced for Zoetis, Jecho, Lilly, Apptec Bio (Shanghai), AZ, Roche, Sotio, Tiantan Bio, Shanghai Pharma, Apeloa, etc.
EU GMP Annex 1 Updating : New challenge for facility
Facility and clean room related key words: Do we really understand them ? For example:
Aseptic Manufacturing Area = Aseptic Processing Facility=Aseptic Processing Room?
Critical Surfaces means? How about Critical areas? How about Aseptically area？
Grade A Air Supply（Local Protection）：How to define the environment monitoring criteria of GAAS？
CNC：New definition，EMPQ new challenge？
Recovery time: how to test?
Root cause discussion.
Core principles of sterile product manufacturing summarize and elaboration.