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已读[58] 发布: 2013/09/02 15:19:19
南方网 对于 FDA认证 的疑问,吴先生解释为公司是遵照着美国药典(USP)的标准生产产品的,并将产品的信息上交给FDA,接受FDA和社会的监督,并不是一个认证的概念。他强调自然之宝从来没有宣传过产品通过了FDA的认证。 不过,记者 ... and more »
已读[71] 发布: 2013/08/31 15:17:10
This is the third in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing. By: Michael R. Taylor As I … Continue reading →
已读[79] 发布: 2013/08/31 15:17:10
By Steven K. Pollack, Ph.D., and James Coburn, M.S. A hospital in Michigan implants a 3-D printed medical device into a 3-month-old boy with a rare bronchial condition and saves a young life. A man has 75 percent of his … Continue reading →
已读[80] 发布: 2013/08/31 15:17:09
This is the fourth in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing.  By: Michael R. Taylor  We did … Continue reading →
已读[76] 发布: 2013/08/31 15:17:08
This is the fifth in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing. By Michael R. Taylor We arrived … Continue reading →
已读[65] 发布: 2013/08/31 15:17:07
This is the sixth in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing.  By: Michael R. Taylor  “Live Free … Continue reading →
已读[74] 发布: 2013/08/31 15:17:06
This is the seventh in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards and preventive controls rule that FDA is proposing as we … Continue reading →
已读[75] 发布: 2013/08/31 15:17:05
By: Michael R. Taylor We all know that healthy adults have consumed caffeine in coffee, tea and chocolate for centuries. Caffeine has also been added to certain soft drinks for many years. These uses of caffeine are considered by most people … Continue reading →
已读[82] 发布: 2013/08/31 15:17:04
By: Lynne Yao, M.D.  We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may … Continue reading →
已读[72] 发布: 2013/08/31 15:17:03
By: David G. White, Ph.D. It’s an impressive sight – 161 posters representing the work of FDA scientists involved in researching food safety and animal health. This third annual food and veterinary science conference taking place at FDA yesterday and … Continue reading →
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通过FDA认证意味着拿到迈向世界的绿卡,而如何通过“FDA认证”与“通过FDA现场检查”是中国医药界心口永远的痛。观念、操作、科学,是我国企业申请“FDA认证“面临的三大挑战。其实FDA并非冷面杀手,世易即将携手美国FDA中国办事处前专职负责审核中国工厂前官员举行系列培训会,帮助中国食品医药企业彻底扫清进入美国市场技术壁垒。 二、专家简介 主讲1:前FDA上海办事处主任Charles A...


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PPT内容 1. 质量体系基础设施 1)依然在实施中 2)双重标准 3)质量体系理念还未根深蒂固 2. 工艺验证 3. 使用者/工艺需求评估  新系统, 新设备-缺乏足够的支持 4. 监督, 记录活动 5. 偏差和OOS的处理和调查 6. 案例分析


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