冯铮铮北京协和药厂质量部QC主管

发布时间：2016-04-27

冯铮铮，北京协和药厂质量部，QC主管

多年就职于北京协和药厂，12年赴起从是QC工作，现任QC主管。熟练运作QC业务，并具有实验室管理经验。

内容摘要：

题目：保持质量控制实验室的持续合规

从彼得·贝克说起，不能让QC成为成为GMP缺陷的重灾区，质量管理是需要成本的;通过加强软件管理保证质控实验室始终处于验证状态;如何推进OOS调查工作;挖掘数据完整性缺陷的真凶。

Feng Zhengzheng, QC Director, Quality Department, Beijing Union Pharmaceutical Factory

Working at Beijing Union Pharmaceutical Factory for many years, engaged in QC since 2012, currently QC Director; familiar with QC business operation, having laboratory management experience

Highlights:

Title: keeping continuous compliance of quality control laboratory

As quoted from Peter Beck, we should not allow QC to be hard hit by GMP defects, quality management entails costs; software management is strengthened to ensure that quality control laboratory is always in the state of validation; how to promote OOS survey; uncover the real cause for data integrity defect.