朱翠翠，杭州科百特过滤器材有限公司实验室主管，专业从事实验室工作、分析方法学研究多年，结合法规，进行数十次的滤芯工艺验证内容分享及培训，熟知化学相容性、溶/析出等分析方法研究，拥有多年相关案例的积累”

Zhu Cuicui, Validation Lab Supervisor in Hangzhou Cobetter Filtration Equipment Co., Ltd who has been focusing on lab work, analytic methodology research of chemical compatibility, extractable test for years. she has been giving dozens of filter process validation training combing the regulation guidelines and her work experience.

“演讲题目：化学相容性&溶析出分析方法的缺陷(风险)探讨及案例分析”

Speech Topic: Discussion on Flaws and Risks of Chemical Compatibility, Extractable Test Methods Discussion and Case Study演讲内容摘要：

中国2010版GMP出台之后，国内制药企业面临着新的挑战，特别是新版GMP对于除菌过滤的要求，除菌过滤器工艺验证作为除菌过滤非常重要的一部分，是制药企业需要重点关注的。

“化学相容性&溶析出验证分析方法的缺陷(风险)探讨及案例分析”将对除菌过滤器工艺验证的化学相容性和溶析出验证涉及到的国内外法规要求、相关的验证方法以及典型案例做深入的剖析，并对部分验证分析方法存在的缺陷进行详细的介绍和分享探讨。

As domestic regulations for sterile filtration become stricter and more in-line with international regulations, it is important for domestically based pharmaceutical companies to understand and adhere to the stricter requirements and guidelines. As such, this speech will discuss the major difference between domestic and international regulations related to chemical compatibility and extractable testing of sterile filter process validation so that those in attendance could note the differences and understand their importance. In addition, this speech also presents and explains the existing risk is current validation analysis methods.