Shen Juping，Vice President and General Manager of Production, Suzhou Kintor Pharmaceutical Limited

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

  Speaker Bio

Shen Juping is currently the Vice President and General Manager of Production 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 "Pre-approval 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.       

 Presentation Summary

The Speech will present the different packaging systems of sterile preparations, and the integrity requirements of GMP and its related regulations for sterile preparation packaging systems; And present the company's solutions for leak detection and sealing system integrity testing and validation for various packaging systems, as well as analysis of common problems faced by the company.