{"id":103732,"date":"2019-02-18T00:00:50","date_gmt":"2019-05-17T08:53:04","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/103732\/"},"modified":"2019-05-17T16:53:05","modified_gmt":"2019-05-17T08:53:05","slug":"62003aa7d5","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/103732\/","title":{"rendered":"\u5357\u4eac\u7ad9|\u751f\u7269\u836f\u7814\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76"},"content":{"rendered":"
\n

\"\u5357\u4eac\u7ad9|\u751f\u7269\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76\"<\/p>\n

\u5404\u6709\u5173\u5355\u4f4d\uff1a
<\/span><\/p>\n

    \u8fd1\u5e74\u6765\uff0c\u751f\u7269\u836f\u7684\u53d1\u5c55\u5f02\u5e38\u8fc5\u731b\uff0c\u4e0d\u7ba1\u662f\u505a\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u751f\u7269\u6280\u672f\u521b\u65b0\u836f\u7269\u7684\u8bde\u751f\uff0c\u8fd8\u662f\u56e0\u4e13\u5229\u5230\u671f\u800c\u7ade\u4e89\u6fc0\u70c8\u7684\u751f\u7269\u4eff\u5236\u836f\u7684\u7814\u53d1\uff0c\u5747\u4f7f\u751f\u7269\u5236\u836f\u6210\u4e3a\u533b\u836f\u884c\u4e1a\u5173\u6ce8\u7684\u70ed\u70b9\u3002\u4e3a\u4e86\u4fc3\u8fdb\u548c\u76d1\u7763\u751f\u7269\u5236\u836f\u884c\u4e1a\u66f4\u597d\u66f4\u5feb\u7684\u53d1\u5c55\uff0c\u5404\u56fd\u7eb7\u7eb7\u51fa\u53f0\u4e86\u76f8\u5173\u653f\u7b56\u3002<\/span><\/p>\n

    \u6211\u56fd\u662f\u4eff\u5236\u836f\u751f\u4ea7\u548c\u4f7f\u7528\u7684\u5927\u56fd\uff0c\u867d\u7136\u56fd\u5185\u5df2\u6709\u5927\u91cf\u751f\u7269\u836f\u54c1\u4e0a\u5e02\uff0c\u4f46\u6211\u56fd\u751f\u7269\u5236\u836f\u7684\u6c34\u5e73\u4ecd\u7136\u4e0d\u9ad8\uff0c\u4ece\u4ea7\u54c1\u7814\u53d1\u5230<\/span>GMP\u751f\u4ea7\u7684\u8d28\u91cf\u7ba1\u7406\u5747\u5b58\u5728\u5de8\u5927\u98ce\u9669\u3002\u5982\u4f55\u5728\u751f\u7269\u836f\u7269\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5229\u7528QbD\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u7684\u7406\u5ff5\uff1f\u5982\u4f55\u63d0\u9ad8\u5236\u836f\u4f01\u4e1a\u7684\u7814\u53d1\u6548\u7387\uff0c\u964d\u4f4e\u7814\u53d1\u6210\u672c\uff1f\u5982\u4f55\u63d0\u9ad8\u751f\u7269\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u51cf\u5c0f\u4e0e\u539f\u7814\u836f\u7684\u5dee\u5f02\u6027\uff1f\u5982\u4f55\u63d0\u9ad8\u6cd5\u89c4\u7684\u7b26\u5408\u6027\uff1f\u5982\u4f55\u51cf\u4f4e\u751f\u7269\u5236\u54c1\u5728\u7533\u62a5\u6ce8\u518c\u4e2d\u7684\u963b\u529b\u7b49\u7b49\uff0c\u8fd9\u4e9b\u90fd\u662f\u751f\u7269\u5236\u836f\u4f01\u4e1a\u9762\u4e34\u7684\u4e25\u91cd\u56f0\u60d1\u4e0e\u6311\u6218\u3002\u4e3a\u6b64\uff0c\u6211\u5355\u4f4d\u5b9a\u4e8e2019\u5e743\u67087-9\u65e5\u5728<\/span>\u5357\u4eac\u5e02<\/span><\/strong>\u4e3e\u529e<\/span>\u201c\u751f\u7269\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76\u201d\u7814\u4fee\u73ed<\/span><\/strong> \u3002\u73b0\u5c06\u6709\u5173\u57f9\u8bad\u4e8b\u9879\u901a\u77e5\u5982\u4e0b\uff1a<\/span><\/span><\/span><\/p>\n

    <\/span><\/strong>\u652f\u6301\u5355\u4f4d\uff1a\u9752\u5c9b\u79d1\u521b\u76f8\u5bb9\u6027\u7814\u7a76\u4e2d\u5fc3\uff08\u9ad8\u5206\u5b50\u6750\u6599\u4e13\u5bb6\u5de5\u4f5c\u7ad9\uff09<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u4f1a\u8bae\u5b89\u6392<\/span><\/strong><\/span><\/p>\n

  \u4f1a\u8bae\u65f6\u95f4\uff1a2019\u5e743\u67087-9\u65e5 (7\u65e5\u5168\u5929\u62a5\u5230)<\/span><\/p>\n

  \u62a5\u5230\u5730\u70b9\uff1a\u5357\u4eac\u5e02  (\u5177\u4f53\u5730\u70b9\u76f4\u63a5\u53d1\u7ed9\u62a5\u540d\u4eba\u5458)<\/span><\/p>\n

\u4e8c\u3001\u4f1a\u8bae\u4e3b\u8981\u4ea4\u6d41\u5185\u5bb9<\/span><\/strong><\/span><\/p>\n

  \u89c1\u65e5\u7a0b\u5b89\u6392\u8868<\/span><\/p>\n

\u4e09\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n

\u5404\u836f\u54c1\u7814\u7a76\u5355\u4f4d\u53ca\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff0c\u751f\u7269\u5236\u5242\u7814\u53d1\u3001\u8d28\u91cf\u3001\u6ce8\u518c\u53ca\u9879\u76ee\u7ba1\u7406\u3001\u7814\u53d1QA\uff1b\u65b0\u53d1CRO\u7b49\u4e2d\u9ad8\u5c42\u7ba1\u7406\u4eba\u5458\u53ca\u7814\u7a76\u8d1f\u8d23\u4eba\u3002<\/span><\/p>\n

\u56db\u3001\u4f1a\u8bae\u8bf4\u660e<\/span><\/strong><\/span><\/p>\n

1\u3001\u7406\u8bba\u8bb2\u89e3,\u5b9e\u4f8b\u5206\u6790,\u4e13\u9898\u8bb2\u6388,\u4e92\u52a8\u7b54\u7591.<\/span><\/p>\n

2\u3001\u4e3b\u8bb2\u5609\u5bbe\u5747\u4e3a\u534f\u4f1a\u57f9\u8bad\u5de5\u4f5c\u5ba4\u4e13\u5bb6\uff0c\u68c0\u67e5\u5458\u548c\u884c\u4e1a\u5185\u76f8\u5173\u8d44\u6df1\u4e13\u5bb6\u3001\u6b22\u8fce\u6765\u7535\u54a8\u8be2\uff0c\u8bfe\u540e\u53ca\u65f6\u8ddf\u8e2a\u8f85\u5bfc\u3002<\/span><\/p>\n

3\u3001\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005\u7531\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66<\/span><\/p>\n

4\u3001\u4f01\u4e1a\u9700\u8981\u5185\u8bad\u548c\u6307\u5bfc\uff0c\u8bf7\u4e0e\u4f1a\u52a1\u7ec4\u8054\u7cfb<\/span><\/p>\n

  <\/span><\/strong><\/span>  \u4e94\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/span><\/strong><\/span><\/p>\n

\u4f1a\u52a1\u8d39\uff1a2500\u5143\/\u4eba\uff08\u4f1a\u52a1\u8d39\u5305\u62ec\uff1a\u57f9\u8bad\u3001\u7814\u8ba8\u3001\u8d44\u6599\u7b49\uff09\u3002\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/p>\n

   <\/span><\/strong><\/span> \u516d\u3001\u8054\u7cfb\u65b9\u5f0f<\/span><\/span><\/strong><\/span><\/p>\n


<\/p>\n

1\u3001\u79fb\u52a8\u7aef\u76f4\u63a5\u626b\u63cf\/\u8bc6\u522b\u4e0b\u65b9\u4e8c\u7ef4\u7801\/\u70b9\u51fb\u201d\u9605\u8bfb\u539f\u6587\u201c\u5373\u53ef\u62a5\u540d\uff1a<\/span><\/strong><\/p>\n

\"\u5357\u4eac\u7ad9|\u751f\u7269\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76\"<\/p>\n

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

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

3. \u8054\u7cfb\u54a8\u8be2\uff1a<\/span><\/strong>
\u7535\u8bdd\/\u5fae\u4fe1\uff1a<\/span>15342234370<\/strong><\/p>\n

\u9644\u4ef6\u4e00\uff1a<\/span> <\/span>          <\/span> <\/span><\/strong>\u65e5<\/span> <\/span>\u7a0b<\/span> <\/span>\u5b89<\/span> <\/span>\u6392<\/span> <\/span>\u8868<\/span><\/strong><\/span><\/p>\n\n\n\n\n
\n

 <\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

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 <\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

\u7b2c\u4e00\u5929<\/span><\/strong><\/span><\/p>\n

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

1<\/span><\/strong>4<\/span><\/strong>:<\/span><\/strong>0<\/span><\/strong>0-1<\/span><\/strong>7<\/span><\/strong>:<\/span><\/strong>0<\/span><\/strong>0<\/span><\/strong><\/span><\/p>\n

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

\n

\u4e00\u3001\u56fd\u5185\u5916\u6cd5\u89c4\u8981\u6c42\u7b80\u8ff0<\/span><\/strong><\/span><\/p>\n

 1.FDA\/\u6b27\u76df\/WHO\/<\/span>\u4e2d\u56fd\u751f\u7269\u836f\u6cd5\u89c4\u89e3\u8bfb\u548c\u6bd4\u8f83<\/span><\/p>\n

  a)FDA\u751f\u7269\u7c7b\u4f3c\u836f\u7684\u6307\u5357\u6587\u4ef6         <\/span><\/p>\n

   b)<\/span>\u6b27\u76df\u300a\u751f\u7269\u7c7b\u4f3c\u836f\u6307\u5357\u300b<\/span><\/p>\n

  c)  WHO\u7684\u300a\u751f\u7269\u7c7b\u4f3c\u836f\u8bc4\u4f30\u6307\u5357\u300b<\/span><\/p>\n

  d)\u4e2d\u56fd\u300a\u751f\u7269\u7c7b\u4f3c\u53d1\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b<\/span><\/p>\n

 2.\u56fd\u5185\u5916\u751f\u7269\u5236\u836f\u7684\u53d1\u5c55\u8d8b\u52bf<\/span><\/p>\n

\u4e8c\u3001 <\/span>CTD<\/span>\u8d44\u6599\u7684\u64b0\u5199\u53ca\u7533\u62a5<\/span><\/span><\/strong><\/span><\/p>\n

 1.CTD\u683c\u5f0f\u6ce8\u518c\u8d44\u6599\u7684\u57fa\u672c\u6784\u6210           <\/span><\/p>\n

 2.\u751f\u7269\u836fCTD<\/span>\u683c\u5f0f\u53ca\u5185\u5bb9\u8ba8\u8bba<\/span><\/p>\n

 3.\u751f\u7269\u836fCTD<\/span>\u7533\u62a5\u8d44\u6599\u7684\u64b0\u5199\u8981\u6c42<\/span><\/p>\n

 4.\u53d8\u66f4\u7814\u7a76\u7684\u6280\u672f\u89c4\u8303\u548c\u57fa\u672c\u539f\u5219<\/span><\/p>\n

   \u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\u7684CMC<\/span>\u53d8\u66f4\/<\/span>\u4e0a\u5e02\u540e\u53d8\u66f4\u7b49   <\/span><\/p>\n

 5.\u56fd\u5185\u5916\u751f\u7269\u836fCTD<\/span>\u7533\u62a5\u6848\u4f8b\u5206\u6790<\/span><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a<\/span><\/strong>\u4e01\u8001\u5e08  \u8d44\u6df1\u4e13\u5bb6\u3001CFDA<\/span>\u9ad8\u7814\u9662\u53ca\u672c\u534f\u4f1a\u7279\u9080\u6388\u8bfe\u8bb2\u5e08\uff0c<\/span>ISPE<\/span>\u4f1a\u5458\uff0c\u719f\u6089\u6b27\u7f8e\u5236\u53ca\u56fd\u5185\u6ce8\u518c\u6cd5\u89c4\uff0c\u8fd1<\/span>20<\/span>\u5e74\u5177\u6709\u836f\u7269\u7814\u53d1\u3001\u836f\u7269\u5de5\u827a\u5f00\u53d1\u3001\u836f\u7269\u5206\u6790\u53ca\u751f\u4ea7\u7ba1\u7406\u7684\u4e30\u5bcc\u5b9e\u8df5\u7ecf\u9a8c\uff0c\u4eb2\u81ea\u53c2\u52a0\u8fc7\u591a\u6b21<\/span>FDA <\/span><\/span>\u3001<\/span>WHO<\/span>\u3001<\/span>TGA<\/span>\u548c<\/span>CEP<\/span>\u8ba4\u8bc1\u53ca\u56fd\u5185\u7684\u68c0\u67e5\u3002<\/span><\/span><\/strong>\u672c\u534f\u4f1a\u53caCFDA<\/span>\u9ad8\u7ea7\u7814\u4fee\u5b66\u9662\u7279\u9080\u8bb2\u5e08\u3002<\/span><\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

 <\/span><\/strong><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

  \u7b2c\u4e8c\u5929<\/span><\/strong><\/span><\/p>\n

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

\u4e09\u3001\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u7684\u751f\u7269\u53d1\u7b56\u7565<\/span><\/strong><\/span><\/p>\n

 1.QbD\u7406\u5ff5\u548c\u5de5\u5177\u4ecb\u7ecd<\/span><\/p>\n

 2.\u7814\u53d1\u4e0e\u8bc4\u4ef7\u7684\u57fa\u672c\u539f\u5219   \u6bd4\u5bf9\/<\/span>\u9010\u6b65\u9012\u8fdb\/<\/span>\u4e00\u81f4\u6027\/<\/span>\u76f8\u4f3c\u6027<\/span><\/p>\n

 3.\u539f\u8f85\u6599\u7684\u8d28\u91cf\u63a7\u5236\u7814\u7a76<\/span><\/p>\n

  a)\u4e0d\u540c\u7ea7\u522b\u539f\u8f85\u6599\u7684\u8d28\u91cf\u63a7\u5236\u8981\u6c42     <\/span><\/p>\n

    b) <\/span><\/span>\u539f\u6599\u836f\u7684\u5236\u5907\u5de5\u827a\u7814\u7a76<\/span><\/p>\n

  c) \u539f\u6599\u836f\u7684\u7ed3\u6784\u786e\u8bc1\u7814\u7a76                <\/span><\/p>\n

    d) <\/span><\/span>\u5305\u6750\u7684\u9009\u62e9\u7814\u7a76<\/span><\/p>\n

 4.\u5904\u65b9\u5de5\u827a\u5f00\u53d1\u7814\u7a76<\/span><\/p>\n

  a)\u5904\u65b9\u7684\u98ce\u9669\u8bc4\u4f30\u53ca\u539f\u578b\u836f\u7269\u7814\u7a76    <\/span><\/p>\n

  b)\u751f\u4ea7\u5de5\u827aCQA<\/span>\u3001CPP<\/span>\u7814\u53d1<\/span><\/p>\n

  c)  \u5c0f\u8bd5\u3001\u4e2d\u8bd5\u3001\u653e\u5927\u7814\u7a76\u7684\u5173\u952e\u70b9<\/span><\/p>\n

\u56db\u3001\u751f\u7269\u836f\u54c1\u8d28\u91cf\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

 1\uff0e\u76f8\u5173\u6cd5\u89c4\u89e3\u6790\uff1aFDA<\/span>\u836f\u54c1\u548c\u751f\u7269\u5236\u54c1\u5206\u6790\u89c4\u7a0b\u548c\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u3001ICH<\/span>\u76f8\u5173\u6cd5\u89c4\u89e3\u6790<\/span><\/p>\n

 2\uff0e\u8d28\u91cf\u6807\u51c6\u7684\u5efa\u7acb\u4e0e\u4fee\u8ba2\uff1a\u5982\u4f55\u4f7f\u7528\u7edf\u8ba1\u5b66\u65b9\u6cd5\u786e\u5b9a\u6807\u51c6<\/span><\/p>\n

 3\uff0e\u8d28\u91cf\u65b9\u6cd5\u5b66\u7814\u7a76\u4e0e\u9a8c\u8bc1\uff1aDOE<\/span>\u5728\u8d28\u91cf\u7814\u7a76\u65b9\u6cd5\u5f00\u53d1\u4e2d\u7684\u5e94\u7528<\/span><\/p>\n

 \u9a8c\u8bc1\uff1a\u4e13\u5c5e\u6027\/<\/span>\u51c6\u786e\u6027\u548c\u7cbe\u786e\u6027\/<\/span>\u7ebf\u6027\/<\/span>\u8303\u56f4\/<\/span>\u8010\u7528\u6027\/<\/span>\u663e\u793a\u7a33\u5b9a\u6027\u7684\u80fd\u529b<\/span><\/p>\n

 4\uff0e\u751f\u7269\u836f\u7279\u6027\u5206\u6790\uff1a\u7406\u5316\u7279\u6027\/<\/span>\u7eaf\u5ea6\u548c\u6742\u8d28\u7684\u5b9a\u6027\u4e0e\u5b9a\u91cf\u5206\u6790\/<\/span>\u751f\u7269\u5b66\u6d3b\u6027\/<\/span>\u514d\u75ab\u5b66\u7279\u6027<\/span><\/p>\n

 5\uff0e\u751f\u7269\u5236\u54c1\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c<\/span><\/p>\n

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