{"id":90462,"date":"2019-04-22T00:00:50","date_gmt":"2019-04-23T04:19:03","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/90462\/"},"modified":"2019-04-23T12:19:08","modified_gmt":"2019-04-23T04:19:08","slug":"23e8bfb573","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/90462\/","title":{"rendered":"\u65b0\u6cd5\u89c4\u4e0b\u7814\u53d1QA\u5c97\u4f4d\u6280\u80fd\u63d0\u5347\u4e0e\u5b8c\u5584"},"content":{"rendered":"
\n

\u5317\u4eac–\u5173\u4e8e\u4e3e\u529e\u201c\u65b0\u6cd5\u89c4\u4e0b<\/span><\/strong>\u7814\u53d1QA\u5c97\u4f4d\u6280\u80fd<\/span><\/strong>\u63d0\u5347\u4e0e\u5b8c\u5584\u4e13\u9898<\/span><\/strong>\u57f9\u8bad<\/span><\/strong>\u73ed\u201d\u7684\u901a\u77e5<\/span><\/strong><\/span><\/strong><\/span><\/p>\n


<\/p>\n

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

\u5236\u836f\u4f01\u4e1a\u7684\u6838\u5fc3\u7ade\u4e89\u529b\u662f\u836f\u54c1\u7814\u53d1\uff0c\u968f\u7740<\/span>CFDA\u52a0\u5165<\/span>ICH<\/span>\u7ec4\u7ec7\u3001\u836f\u5ba1\u6539\u9769\u3001\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u7b49\uff0c\u5404\u79cd\u65b0\u653f\u6b63\u5728\u6539\u53d8\u6211\u56fd\u836f\u54c1\u7814\u53d1\u683c\u5c40\u3002<\/span><\/span>\u6211\u56fd\u867d\u4f5c\u4e3a\u4eff\u5236\u53d1\u5927\u56fd\uff0c\u4f46\u56fd\u9645\u5316\u7684\u4e0d\u65ad\u52a0\u6df1\uff0c\u5728\u50ac\u751f\u65b0\u673a\u9047\u7684\u540c\u65f6\u4e5f\u5e26\u6765\u4e86\u65b0\u7684\u6311\u6218\u3002\u5728\u673a\u4f1a\u4e0e\u6311\u6218\u5e76\u5b58\u7684\u65f6\u4ee3\u91cc\uff0c\u5982\u4f55\u63d0\u5347\u836f\u7269\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u7684\u7ba1\u7406\u6c34\u5e73\uff1f\u5982\u4f55\u4ece\u7cfb\u7edf\u4e0e\u7ba1\u7406\u4e0a\u907f\u514d\u7814\u53d1\u98ce\u9669\uff1f\u5982\u4f55\u63d0\u5347\u836f\u7269\u7814\u53d1\u56e2\u961f\u7684\u4e13\u4e1a\u6280\u80fd\uff1f\u8fd9\u4e9b\u90fd\u662f\u76ee\u524d\u5236\u836f\u4f01\u4e1a\u666e\u904d\u5b58\u5728\u7684\u56f0\u60d1\u53ca\u9762\u4e34\u7684\u95ee\u9898\u3002\u4e3a\u4e86\u5e2e\u52a9\u5236\u836f\u4f01\u4e1a\u63d0\u9ad8\u836f\u54c1\u7814\u53d1<\/span>QA<\/span>\u5c97\u4f4d\u7684\u6c34\u5e73\uff0c\u638c\u63e1\u56fd\u5185\u5916\u836f\u54c1\u7814\u53d1\u7684\u65b0\u52a8\u5411\uff0c\u5168\u9762\u63d0\u5347\u836f\u54c1\u7814\u53d1<\/span>QA<\/span>\u7684\u5de5\u4f5c\u80fd\u529b\u548c\u804c\u4e1a\u7d20\u517b\uff0c\u52a0\u5f3a<\/span>QbD<\/span>\u7406\u5ff5\u5728\u7814\u53d1\u4e2d\u7684\u5e94\u7528\u5de5\u4f5c\u7684\u5f00\u5c55\uff0c\u63a2\u8ba8\u548c\u6539\u8fdb\u7814\u53d1\u5b9e\u9645\u5de5\u4f5c\u4e2d\u5b58\u5728\u7684\u95ee\u9898\uff0c\u63d0\u5347\u6211\u56fd\u4eff\u5236\u836f\u4e0e\u65b0\u53d1\u7684\u8d28\u91cf\u548c\u6548\u7387\u3002<\/span><\/span>\u4e3a\u6b64\uff0c\u672c\u5355\u4f4d\u5b9a\u4e8e<\/span>201<\/span>9<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>23<\/span>\u65e5\u81f3<\/span>25<\/span>\u65e5\u5728<\/span>\u5317<\/span>\u4eac\u5e02\u4e3e\u529e<\/span>\u201c<\/span>\u65b0\u6cd5\u89c4\u4e0b<\/span>\u7814\u53d1<\/span>QA\u5c97\u4f4d\u6280\u80fd<\/span><\/span>\u63d0\u5347\u4e0e\u5b8c\u5584\u4e13\u9898<\/span>\u57f9\u8bad<\/span>\u73ed<\/span>\u201d\uff0c<\/span><\/span>\u5c4a\u65f6<\/span>\u9080\u8bf7\u4e1a\u5185\u6743\u5a01\u4e13\u5bb6\u9488\u5bf9\u76f8\u5173<\/span>\u95ee\u9898\u8fdb\u884c\u6df1\u5165\u89e3\u6790<\/span>\u3002<\/span><\/span><\/span>\u901a\u77e5\u5982\u4e0b\uff1a<\/span><\/span><\/span><\/span><\/p>\n

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

   \u4f1a\u8bae\u65f6\u95f4\uff1a<\/span>2019\u5e745\u670823-25\u65e5(23\u65e5\u5168\u5929\u62a5\u5230)<\/span><\/p>\n

   \u62a5\u5230\u5730\u70b9\uff1a<\/span>\u5317\u4eac\u5e02  (\u5177\u4f53\u5730\u70b9\u76f4\u63a5\u53d1\u7ed9\u62a5\u540d\u4eba\u5458)<\/span><\/span><\/p>\n

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

    \u8be6\u89c1\u9644\u4ef6\u4e00\uff08\u65e5\u7a0b\u5b89\u6392\u8868)<\/span><\/p>\n

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

    \u4ece\u4e8b\u836f\u54c1\u7814\u53d1\u8d28\u91cf\u4eba\u5458\u3001\u7814\u53d1\u4eba\u5458\u53ca\u5176\u4ed6\u76f8\u5173\u4eba\u5458<\/span><\/p>\n

\u56db\u3001\u4f1a\u8bae\u8bf4\u660e<\/span><\/strong><\/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\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005<\/span>\u7531<\/span>\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66<\/span><\/span><\/span><\/p>\n

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

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

\u4f1a\u52a1\u8d39\uff1a<\/span>2500\u5143<\/span>\/\u4eba\uff08<\/span>\u4f1a\u52a1\u8d39\u5305\u62ec\uff1a<\/span>\u57f9\u8bad\u3001\u7814\u8ba8\u3001<\/span>\u8bc1\u4e66<\/span>\/\u8d44\u6599\u7b49\uff09<\/span>\uff1b<\/span><\/span>\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/span><\/span><\/p>\n

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

\u62a5\u540d\u8054\u7cfb\u4eba<\/span>:<\/span><\/strong>\u5c1a\u4e39<\/span><\/strong> 15652565785<\/span><\/strong>\u540c\u5fae\u4fe1<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u90ae<\/span>\u7bb1\uff1a<\/span><\/span><\/strong><\/span><\/strong>2331466365@qq.com<\/span><\/strong> <\/span><\/strong>QQ<\/span><\/strong>                          <\/span><\/span><\/p>\n

\"\u65b0\u6cd5\u89c4\u4e0b\u7814\u53d1QA\u5c97\u4f4d\u6280\u80fd\u63d0\u5347\u4e0e\u5b8c\u5584\"<\/p>\n

\u53ef\u8bc6\u522b\u4e8c\u7ef4\u7801\u586b\u5199\u56de\u6267\u62a5\u540d<\/span> <\/span><\/p>\n

\u9644\u4ef6\u4e00\uff1a<\/span><\/strong><\/span><\/strong>\u4f1a\u8bae\u65e5\u7a0b\u5b89\u6392<\/span><\/span><\/p>\n

   \u9644\u4ef6\u4e8c\uff1a<\/strong><\/span><\/span><\/span><\/strong>\u53c2\u4f1a\u62a5\u540d\u8868<\/span><\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n

\u5317\u4eac\u534e\u590f\u51ef\u665f\u533b\u836f\u6280\u672f\u4e2d\u5fc3<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

                                <\/span><\/strong>\u4e8c<\/span>\u25cb\u4e00<\/span><\/strong>\u4e5d<\/span><\/strong>\u5e74<\/span><\/strong>\u56db<\/span><\/strong>\u6708<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u9644\u4ef6\u4e00\uff1a<\/span><\/strong>\u4f1a\u8bae\u65e5\u7a0b\u5b89\u6392<\/span><\/span><\/p>\n\n\n\n\n
\n

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

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

14:00-17:00<\/span><\/strong><\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u4e00\u3001\u7814\u53d1QA\u9700\u8981\u638c\u63e1\u7684\u6cd5\u89c4<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

1\u3001\u6211\u56fd\u73b0\u6709\u836f\u54c1\u7814\u53d1\u76f8\u5173\u6cd5\u89c4\u4f53\u7cfb<\/span><\/p>\n

\u65b0\u836f\u54c1\u6ce8\u518c\u5206\u7c7b\u7b80\u6790\u53ca\u8d28\u91cf\u4f53\u7cfb\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u76f8\u5173\u653f\u7b56<\/span><\/p>\n

\u836f\u7269\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

2\u3001\u56fd\u9645\u836f\u7269\u7814\u53d1\u76f8\u5173\u6cd5\u89c4\u89e3\u6790<\/span><\/p>\n

ICH\u7cfb\u7edf\u6cd5\u89c4\u67b6\u6784\u4f53\u7cfbCTD\u6587\u4ef6\u5bf9\u836f\u7269\u7814\u53d1\u7684\u8981\u6c42<\/span><\/p>\n

FDA\u836f\u54c1\u7814\u53d1\u6307\u5357\/\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u6307\u5bfc\u6307\u5357<\/span><\/p>\n

\u5168\u7403\u65b0\u53d1\u7279\u70b9\u53ca\u8fdb\u5c55\u4e0e\u4e2d\u56fd\u836f\u4f01\u7684\u673a\u9047<\/span><\/p>\n

\u4e8c\u3001\u5982\u4f55\u5efa\u7acb\u6709\u9488\u5bf9\u6027\u7684\u7814\u53d1\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

1\u3001\u5982\u4f55\u7ec4\u5efa\u7814\u53d1\u8d28\u91cf\u56e2\u961f<\/span><\/p>\n

2\u3001\u836f\u7269\u7814\u53d1\u7684\u4e00\u822c\u6d41\u7a0b<\/span><\/p>\n

\u4f01\u4e1a\u5e94\u8be5\u5efa\u7acb\u54ea\u4e9b\u7814\u53d1SOP\uff08\u5206\u522b\u4ee5\u65b0\u836f\u548c\u4eff\u5236\u836f\u4e3e\u4f8b\uff09<\/span><\/p>\n

QA\u4e13\u5458\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u7684\u4ecb\u5165\u8282\u70b9QA\u4e13\u5458\u5728\u7533\u62a5\u8fc7\u7a0b\u4e2d\u7684\u628a\u63a7\u73af\u8282<\/span><\/p>\n

\u5982\u4f55\u5bf9\u7814\u53d1\u4eba\u5458\u5f00\u5c55\u9488\u5bf9\u6027\u57f9\u8bad<\/span><\/p>\n

\u533b\u836f\u6cd5\u89c4\u57f9\u8bad\u5408\u6210\/\u8d28\u91cf\u7814\u7a76\u64cd\u4f5c\u57f9\u8bad\u8bbe\u5907\u4f7f\u7528\u64cd\u4f5c\u57f9\u8bad<\/span><\/p>\n

\u6848\u4f8b\u5206\u6790\u53ca\u73b0\u573a\u8ba8\u8bba\u4e92\u52a8<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u4e3b\u8bb2\u8001\u5e08\uff1a<\/span><\/strong><\/span><\/strong>\u97e9\u8001\u5e08,\u4efb\u804c\u4e8e\u56fd\u5185\u9f99\u5934\u5236\u836f\u4f01\u4e1a,\u4e3b\u6293\u96c6\u56e2\u836f\u54c1\u7814\u53d1QA\u5de5\u4f5c\uff0c\u719f\u6089\u76f8\u5173\u653f\u7b56\u6cd5\u89c4\u53ca\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u5efa\u8bbe\u7b49\u5de5\u4f5c\u53ca\u5b9e\u65bd\uff0c\u5bf9\u7814\u53d1QA\u5de5\u4f5c\u6709\u6df1\u523b\u7406\u89e3\uff0c\u5728\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u5efa\u8bbe\u63a2\u7d22\u5b9e\u8df5\u4e2d\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7684\u7ecf\u9a8c\uff1b\u4ece\u836f\u54c1\u751f\u4ea7\u5230\u836f\u54c1\u7814\u53d1\u5206\u522b\u4ece\u4e8b\u4e86\u7ea610\u4f59\u5e74\u7684\u5de5\u4f5c\u7ecf\u5386\uff1b\u8bfe\u7a0b\u8bb2\u89e3\u6ce8\u91cd\u5177\u4f53\u5de5\u4f5c\u7684\u5b9e\u65bd\u3001\u6848\u4f8b\u7684\u89e3\u6790\u53ca\u7ecf\u9a8c\u7684\u5206\u4eab\uff0c\u672c\u534f\u4f1a\u7279\u9080\u8bb2\u5e08<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

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

14:00-17:00<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

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

\n

 <\/span><\/strong><\/span><\/p>\n

QA\u4e3b\u5bfc\u5c06QbD\u5e94\u7528\u4e8e\u5de5\u827a\u7814\u53d1\u751f\u547d\u5468\u671f<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

1. \u57fa\u4e8eQbD\u7406\u5ff5\u7684\u836f\u7269\u7814\u53d1\u8fc7\u7a0b<\/span><\/p>\n

QTPP\/CQA\/CPPICH Q11 \u539f\u6599\u836f\u5f00\u53d1\u4e0e\u5236\u9020<\/span><\/p>\n

ICH Q8 \u836f\u7269\u5f00\u53d1\/\u5316\u5b66\u836f\u7269\u5236\u5242\u7814\u7a76\u57fa\u672c\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

2. \u5de5\u827a\u7814\u53d1\u8fc7\u7a0b\u7684\u8d28\u91cf\u53c2\u4e0e\u548c\u628a\u63a7<\/span><\/p>\n

a) QA\u4e3b\u5bfc\u7684\u98ce\u9669\u5206\u6790\u6d41\u7a0b<\/span><\/p>\n

b) \u6848\u4f8b\uff1a\u836f\u54c1\u5904\u65b9\u7814\u7a76\u7684\u6280\u672f\u5173\u952e\u70b9\u89e3\u6790<\/span><\/p>\n

c) \u6848\u4f8b\uff1a\u539f\u8f85\u5305\u9009\u62e9\u7684\u8d28\u91cf\u63a7\u5236<\/span><\/p>\n

d) \u5c0f\u8bd5\u3001\u4e2d\u8bd5\u3001\u653e\u5927\u7814\u7a76\u7684\u5173\u952e\u70b9\u53ca\u98ce\u9669\u5206\u6790<\/span><\/p>\n

e) \u5982\u4f55\u79d1\u5b66\u5256\u6790\u539f\u7814\/\u53c2\u6bd4\u5236\u5242<\/span><\/p>\n

f) \u5982\u4f55\u5e94\u7528\u98ce\u9669\u7ba1\u7406\u89e3\u51b3\u5de5\u827a\u7814\u53d1\u4e2d\u7684\u5173\u952e\u6027\u96be\u9898\uff08\u504f\u5dee\u63a7\u5236\uff09<\/span><\/p>\n

3. \u65b9\u6cd5\u5f00\u53d1\u8fc7\u7a0b\u7684\u8d28\u91cf\u53c2\u4e0e\u548c\u628a\u63a7<\/span><\/p>\n

\u6742\u8d28\u7814\u7a76\u6cd5\u89c4\u4e0e\u63a7\u5236\u601d\u8def\u901a\u8fc7\u98ce\u9669\u5206\u6790\u5236\u5b9a\u6742\u8d28\u9650\u5ea6<\/span><\/p>\n

\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u53ca\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u683c\u5f0f\u5ba1\u6838<\/span><\/p>\n

4. \u5de5\u827a\u53ca\u65b9\u6cd5\u8f6c\u79fb\u7684\u8d28\u91cf\u63a7\u5236<\/span><\/p>\n

QA\u4e3b\u5bfc\u56e2\u961f\u5f00\u5c55\u7814\u53d1\u5230\u751f\u4ea7\u7684\u5de5\u827a\u53ca\u65b9\u6cd5\u8f6c\u79fb<\/span><\/p>\n

\u836f\u54c1\u7814\u53d1\u95ee\u9898\u7684\u8d28\u91cf\u4e3b\u5bfc\u95ee\u9898<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

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\u624b \u673a<\/span><\/p>\n<\/td>\n<\/tr>\n


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\u4f4f\u5bbf\u662f\u5426\u9700\u8981\u5355\u95f4\uff1a\u662f\u25cb \u5426\u25cb<\/span><\/p>\n<\/td>\n

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\u5165\u4f4f\u65f6\u95f4\uff1a\u65e5\u81f3\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u94f6\u884c\u6c47\u6b3e\u81f3\uff1a<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

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\u95ee\u98981\u3001<\/span><\/p>\n

\u95ee\u98982<\/span>\u3001<\/span><\/span><\/strong><\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u62a5\u540d\u8054\u7cfb\u4eba:<\/span><\/strong>\u5c1a\u4e39<\/span><\/strong> 15652565785<\/span><\/strong>\u540c\u5fae\u4fe1<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u90ae \u7bb1\uff1a<\/span><\/strong><\/span><\/strong>2331466365@qq.com<\/span><\/strong> <\/span><\/strong>QQ<\/span><\/strong>                          <\/span><\/span><\/p>\n

\u53ef\u8bc6\u522b\u4e8c\u7ef4\u7801\u586b\u5199\u56de\u6267\u62a5\u540d <\/span><\/p>\n

 <\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n","protected":false},"excerpt":{"rendered":"

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