{"id":106429,"date":"2019-04-01T00:00:50","date_gmt":"2019-05-17T09:10:13","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/106429\/"},"modified":"2019-05-17T17:10:14","modified_gmt":"2019-05-17T09:10:14","slug":"62dcb40938","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/106429\/","title":{"rendered":"\u7b26\u5408\u56fd\u5185\u5916\u6cd5\u89c4\u8981\u6c42\u7684\u5de5\u827a\u9a8c\u8bc1\u6df1\u5ea6\u89e3\u6790\u4e0e\u5b9e\u65bd\u5e94\u7528"},"content":{"rendered":"
\n

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    \u4e3a\u6b64\uff0c\u672c\u6b21\u57f9\u8bad\u4eceFDA\u3001EMA\u53caNMPA\u6cd5\u89c4\u4e3a\u51fa\u53d1\u70b9\uff0c\u4ee5FDA\u5b98\u65b9\u53d1\u5e03\u7684\u6307\u5bfc\u539f\u5219\u4e3a\u57fa\u7840\uff0c\u8bb2\u89e3\u56fd\u5185\u836f\u5382\u7684\u5b9e\u8df5\u5b9e\u4f8b\uff0c\u540c\u65f6\uff0c\u5728\u8bb2\u89e3\u8fc7\u7a0b\u4e2d\u9610\u8ff0\u4f01\u4e1a\u5728\u5b9e\u8df5\u8fc7\u7a0b\u4e2d\u4f1a\u9047\u5230\u7684\u5e38\u89c1\u95ee\u9898\uff0c\u76f8\u4fe1\uff0c\u5bf9\u4e8e\u836f\u4f01\u7b49\u76f8\u5173\u4eba\u5458\u90fd\u975e\u5e38\u6709\u5e2e\u52a9\u3002\u9274\u4e8e\u6b64\uff0c\u6211\u5355\u4f4d\u5b9a\u4e8e2019\u5e745\u67089-11\u65e5\u5728\u5317\u4eac\u5e02\u4e3e\u529e<\/span>\u201c\u7b26\u5408\u56fd\u5185\u5916\u6cd5\u89c4\u8981\u6c42\u7684\u5de5\u827a\u9a8c\u8bc1\u6df1\u5ea6\u89e3\u6790\u4e0e\u5b9e\u65bd\u5e94\u7528\u201d\u4e13\u9898\u7814\u4fee\u73ed<\/span><\/strong>\u3002\u73b0\u5c06\u6709\u5173\u57f9\u8bad\u4e8b\u9879\u901a\u77e5\u5982\u4e0b\uff1a<\/span><\/span><\/p>\n

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2\u3001\u7535\u8111\u7aef\u8bf7\u590d\u5236\u4e0b\u65b9\u94fe\u63a5\u8fdb\u884c\u62a5\u540d<\/span><\/strong>
<\/p>\n

http:\/\/swzpq520.mikecrm.com\/LWNxF5t<\/p>\n

3. \u8054\u7cfb\u54a8\u8be2\uff1a<\/span><\/strong>
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09:00-12:00<\/span><\/strong><\/span><\/p>\n

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\n

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1.FDA\u5de5\u827a\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

 a)\u8fd1\u4e24\u5e74\u5173\u4e8e\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e0d\u8db3\u7684\u8d8b\u52bf\u7edf\u8ba1<\/span><\/p>\n

 b)\u56fd\u5185\u53ca\u5370\u5ea6483<\/span>\u8b66\u544a\u4fe1\u8be6\u89e3<\/span><\/p>\n

2.\u6b27\u76dfEU GMP<\/span>\u9644\u5f5515<\/span><\/span><\/p>\n

3.\u4e2d\u56fdGMP<\/span>\u53ca\u5b9e\u65bd\u6307\u5357\u4e2d\uff0c\u5bf9\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42<\/span><\/p>\n

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1.\u5b9e\u65bd\u5de5\u827a\u9a8c\u8bc1\u7684\u6761\u4ef6<\/span><\/p>\n

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 b)\u4e0d\u540c\u7ea7\u522b\u7684\u53d8\u66f4\u5982\u4f55\u8fdb\u884c\u5de5\u827a\u518d\u9a8c\u8bc1<\/span><\/p>\n

 c)\u5982\u4f55\u4fdd\u8bc1\u65e5\u5e38\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5bf9\u9a8c\u8bc1\u72b6\u6001\u7a33\u5b9a\u53ef\u63a7<\/span><\/p>\n

 d)\u65e7\u751f\u4ea7\u7ebf\u5982\u4f55\u5b9e\u65bd\u65b0\u5de5\u827a\u9a8c\u8bc1\u601d\u8def<\/span><\/p>\n

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 a)QbD\u6982\u5ff5\u7684\u751f\u547d\u5468\u671f\u5e94\u7528<\/span><\/p>\n

 b)\u7814\u53d1\u548c\u751f\u4ea7\u56e2\u961f\u5982\u4f55\u6574\u5408<\/span><\/p>\n

3.\u5de5\u827a\u9a8c\u8bc1\u5982\u4f55\u64b0\u5199\u4e09\u4e2a\u9636\u6bb5\u7684\u9a8c\u8bc1\u65b9\u6848<\/span><\/p>\n

 a)\u6210\u529f\u5de5\u827a\u9a8c\u8bc1\u7684\u51e0\u8981\u7d20\uff08\u5145\u5206\u6587\u4ef6\u3001\u7ed3\u679c\u7a33\u5b9a\u3001\u8d28\u91cf\u6807\u51c6\uff09<\/span><\/p>\n

 b)\u9a8c\u8bc1\u65b9\u6848\u5e94\u907f\u514d\u7684\u51e0\u4e2a\u96f7\u533a<\/span><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a<\/span><\/strong>\u5b89\u8001\u5e08, \u67d0\u5927\u578b\u533b\u836f\u96c6\u56e2\u8d28\u91cf\u4e0e\u6cd5\u89c4\u603b\u76d1 \u4e3b\u8981\u4ece\u4e8bFDA\u5e02\u573a\u7684\u4ea7\u54c1cGMP\u8fd0\u4f5c ,\u4ece\u4e8b\u5236\u5242\u53ca\u539f\u6599\u53d1\u53ca\u8d28\u91cf\u76f8\u5173\u7ba1\u7406\u5de5\u4f5c\u8fd120\u5e74\u3002\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u672c\u534f\u4f1a\u7279\u8058\u8bb2\u5e08\u3002<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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09:00-12:00<\/span><\/strong><\/span><\/p>\n

13:30-16:30<\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

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1.\u5de5\u827a\u8bbe\u8ba1Process Design<\/span><\/span><\/p>\n

 a)\u7814\u53d1\u8fc7\u7a0b\u4e2d\u7684\u5de5\u827a\u77e5\u8bc6\u6765\u6e90\u53ca\u5b58\u50a8<\/span><\/p>\n

 b)\u5de5\u827a\u8bbe\u8ba1QbD<\/span>\u77e5\u8bc6\u67b6\u6784\u7684\u5efa\u7acb<\/span><\/p>\n

 c)\u7814\u53d1\u8fc7\u7a0b\u5982\u4f55\u4f7f\u7528\u98ce\u9669\u7ba1\u7406\u5de5\u5177\u8fdb\u884c\u5de5\u827a\u5206\u6790<\/span><\/p>\n

 d)\u4e3e\u4f8b\u5206\u6790\uff1a\u5e94\u7528QbD<\/span>\u539f\u5219\u786e\u8ba4\u5173\u952e\u8d28\u91cf\u5c5e\u6027CQA<\/span>\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570CPP<\/span>\u3001\u5173\u952e\u7269\u6599\u5c5e\u6027CMA<\/span><\/span><\/p>\n

2.\u5de5\u827a\u6027\u80fd\u786e\u8ba4Process Performance Qualification-PPQ<\/span><\/span><\/p>\n

 a )\u5982\u4f55\u786e\u5b9a\u6027\u80fd\u786e\u8ba4\u9636\u6bb5\u7684\u6279\u91cf\u548c\u89c4\u683c\u548c\u53d6\u6837\u8ba1\u5212<\/span><\/p>\n

 b)\u5982\u4f55\u786e\u8ba4PPQ<\/span>\u9636\u6bb5\u4e2d\u7684\u6279\u91cf\u3001\u6279\u6b21<\/span><\/p>\n

 c)\u4e3e\u4f8b\u5206\u6790\uff1a\u9488\u5bf9\u67d0\u5177\u4f53\u54c1\u79cd\u5b9e\u65bdPPQ<\/span>\u53ca\u5173\u952e\u8981\u70b9\u89e3\u6790<\/span><\/p>\n

3.\u6301\u7eed\u5de5\u827a\u786e\u8ba4 Continued Process Verification-CPV<\/span><\/span><\/p>\n

 a)\u521d\u671f\u6279\u6b21\uff083A<\/span>\u671f\uff09\u7684\u52a0\u5f3a\u76d1\u6d4b\u8ba1\u5212\u5236\u5b9a<\/span><\/p>\n

 b)\u65e5\u5e38\u6279\u6b21\uff083B<\/span>\u671f\uff09\u751f\u4ea7\u76d1\u6d4b\u8ba1\u5212\u5236\u5b9a<\/span><\/p>\n

 c)\u5de5\u827a\u98d8\u79fb\u548c\u7edf\u8ba1\u8d8b\u52bf\u7684\u5173\u6ce8\u70b9<\/span><\/p>\n

 d)\u4e3e\u4f8b\u5206\u6790\uff1a\u67d0\u54c1\u79cd\u7684\u65e5\u5e38\u76d1\u6d4b\u65b9\u5f0f\u53ca\u7edf\u8ba1\u5de5\u5177<\/span><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a<\/span><\/strong> <\/strong>\u5434\u8001\u5e08  \u8d44\u6df1\u4e13\u5bb6  \u957f\u671f\u5728\u8de8\u56fd\u4f01\u4e1a\u5de5\u4f5c\uff0c\u5386\u4efb\u9a8c\u8bc1\u7ecf\u7406\uff0cQA <\/span>\u603b\u76d1\uff0c\u5de5\u827a\u603b\u76d1\u3002 \u53c2\u4e0e\u7684\u9879\u76ee\u5f88\u591a\u901a\u8fc7\u4e86EU, FDA <\/span>\u7684GMP <\/span>\u5ba1\u8ba1\uff0c\u6709\u774020<\/span>\u591a\u5e74\u7684\u5236\u836f\u884c\u4e1a\u5de5\u827a\u8bbe\u8ba1\u548c\u9a8c\u8bc1\u7684\u7ecf\u9a8c\u3002\u719f\u6089\u65e0\u83cc\uff0c \u53e3\u670d\u7684\u5236\u5242\u5de5\u827a\u3002\u672c\u534f\u4f1a\u7279\u9080\u4e13\u5bb6<\/span><\/strong><\/span><\/p>\n


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\u6b22\u8fce\u626b\u63cf\u4e8c\u7ef4\u7801\u52a0\u5c0f\u7f16\u5fae\u4fe1\u54a8\u8be2\uff01<\/span><\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u7b26\u5408\u56fd\u5185\u5916\u6cd5\u89c4\u8981\u6c42\u7684\u5de5\u827a\u9a8c\u8bc1\u6df1\u5ea6\u89e3\u6790\u4e0e\u5b9e\u65bd\u5e94\u7528\"<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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