搜索FDA检查员信息

kslam

FDA检查准备计划的诀窍是先了解检查员背景。这至关重要的检查员如下信息可从商业数据公司购买。

• 他们有多少年的经验?
• 他们检查过哪些公司？
• 他们发出483缺陷单的比例?
• 他们完成的检查导致了多少封警告信?
• 他们的专业技能是什么?
  

例如彼得贝克 (Peter Baker) - 他完成的检查共发出29封警告信。2017年70％的检查结果导致483缺陷单。他在过去几年中主要在中国进行检查，在此之前他在印度。

他专注于实验室，程序和书面记录。




摘录FDAzilla 数据库

beiwei5du

• Acting Associate Director for Medical Product Investigations in the FDA China Office
• Previously spent 2 ½ years inspecting pharmaceutical firms in India
• He has a master’s degree in Analytical Chemistry
• Speaker at the PDA Data Integrity Workshop in Beijing, China in June 2015
• Before his work at the FDA, he worked in the pharmaceutical industry
• He’s a seasoned, serious investigator who has been physically threatened on some of his inspections by the firms that he is inspecting: http://www.financialexpress.com/archive/usfda-says-team-threatened-during-wockhardt-inspection/1255079/
• He has a solid 5 o’clock shadow (see below)
  

这个就是我们中国人说的太较真了，一根经，早晚要怼起来！！！！

184000197

，楼主厉害了

beiwei5du

这个：
On 03/20/13, investigators were served unsealed water bottles, and each investigator developed stomach problems during the course of the inspection.
哈哈！以后检察官检查要只带食品和饮料，防止被暗算啊！

一沙一叶

beiwei5du 发表于 2018-3-2 14:01
这个：
On 03/20/13, investigators were served unsealed water bottles, and each investigator develop ...

这个是从哪里弄的

beiwei5du

一沙一叶 发表于 2018-3-2 15:34
这个是从哪里弄的

就是上面的那个链接：
USFDA says team threatened during Wockhardt inspection
http://www.financialexpress.com/ ... inspection/1255079/