FDA审厂管理系统20160504.pptxVIP

FDA Inspection Management SystemFDA审厂管理系统高级工程师ISO TC121 /SC3 成员Mobile: Q/WeiXin:mail : mailto:chenxingwen@chenxingwen@怡和嘉业医疗科技法规注册部 陈兴文2016 05Inspection “Do’s”检查时“需做的事”Inspection “Donts”检查时“不可做的事”Roles and Responsibilities角色与职责 Front Room—Back RoomA Communication Methodology前室—后室交流方法Front Room Operational Methods前室运作方式Back Room Operational Methods 后室运作方式VISUAL MANAGEMENT WALL可视化管理墙Top 10 Steps towards a successful FDA assessment成功通过FDA审核的10步QA准备工作策划Index目录Be pleasant, hospitable, businesslike. Smile when introduced.愉快、热情、条理清晰。介绍时面带微笑。When answering questions:回答问题时，