美国FDA顾问药品生驳您企业验证培训(中英对照).pdfVIP

FUNDAMENTALS AND ESSENTIALS OF VALIDATION 验证基础及实质 Michael Anisfeld （Dr.麦克.安斯菲尔得） Globepharm Consulting 1 © Copyright Globepharm, 2005 课程安排COURSE SCHEDULE INTRODUCTION + REGULATORY ENVIRONMENT 介绍＋法规环境 VALIDATION BASICS 验证基础知识 VALIDATION MASTER PLANS 验证主文件 PROCESS VALIDATION 工艺验证 UTILITIES VALIDATION 公用系统验证 CLEANING VALIDATION 清洁验证 COMPUTER VALIDATION 计算机系统验证 ANALYTICAL METHOD VALIDATION 分析方法验证 CASE STUDY 案例研究 2 © Copyright Globepharm, 2005 Housekeeping Course Notes 课程注意 Master List Surveys Are You Lost ? English – American ? Mobile Phone–Beepersrs Restrooms Fire Drill Breaks and Ending Messages from Office Airport ? 3 © Copyright Globepharm, 2005 培训期间During this Training Session If如果: 1. I go too fast 我讲的太快 2.I use strange words 我使用陌生词语 3.I get too technical 我讲的太专业 Please Interrupt and Ask …. There Is No Such Thing As A Silly Question 请随时打断我，并提问。。。。