Topic：Sterile Preparation Guarantee System Integrity Test Regulatory Requirements and Solutions   

Shen Juping is currently the Deputy General Manager of Suzhou Kintor Pharmaceutical Limited. For more than 20 years, he has been engaged in the production, quality and project management of the pharmaceutical industry. He has cross-cultural work and management experience, and has worked in European, American, Japanese and local companies.            

He has very rich theoretical knowledge and practical experience in the production, quality, equipment, validation and process of drugs, especially sterile drugs. Familiar with major GMP regulations in China and abroad, and have rich experience in inspection and certification of China GMP, EU GMP and Japanese GMP, and have many successful cases. He is one of the main drafters and revisers of China's 2010 version of GMP, the main editor of the "Guidelines for the Implementation of Pharmaceutical GMP"-"Sterile Drugs", and assisted in revising the "Quality Management System", "Utilities and Facilities" and other guidelines, expert reviewer member of "Preapproval Inspection for Drug Registration". Hundreds of public lectures and trainings were conducted for SFDA, drug regulatory systems of various provinces and cities, and various industry forums. He is now a member of the expert group of CPAPE.