Znn3bq.jpeg
²é¿´: 1423  |  »Ø¸´: 6
µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû

³½·âÍøÊÂ

гæ (СÓÐÃûÆø)

[ÇóÖú] FDAÈÏÖ¤ ÒÑÓÐ3È˲ÎÓë

FDAÈÏ֤עÒâÊÂÏÇó´Í½Ì¡£

·¢×ÔСľ³æAndroid¿Í»§¶Ë
»Ø¸´´ËÂ¥

» ²ÂÄãϲ»¶

ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

ning_zilv

ľ³æ (ÕýʽдÊÖ)

ÄãÎʵÄÎÊÌâºÃ´óѽ£¿
3Â¥2017-09-12 22:27:04
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
²é¿´È«²¿ 7 ¸ö»Ø´ð

yyajie

ľ³æ (СÓÐÃûÆø)

¡¾´ð°¸¡¿Ó¦Öú»ØÌû

¸Ðл²ÎÓ룬ӦÖúÖ¸Êý +1
²»ÒªÔì¼Ù£¬½âÊÍÄܽâÊ͵ģ¬Ïë°ì·¨½â¾ö²»ÄܽâÊ͵ģ¬ÌåϵҪÍêÕû£¬ÒªÓÐÄãµÄ¿ØÖÆ¡£
ÒìÏëÌ쿪£¬µ¨´óÐÄϸ£¡
2Â¥2017-09-05 09:44:33
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

lubenle

ÖÁ×ðľ³æ (ÖøÃûдÊÖ)

¡¾´ð°¸¡¿Ó¦Öú»ØÌû

Be prepared£¨Ê±¿Ì×¼±¸×Å£©
Be professional£¨×¨Òµ£©
Project a positive, confident attitude£º»ùÓÚÊÂʵµÄ×ÔÐÅListen CAREFULLY to the question£¨Ìý¶®ÎÊÌ⣩
Wait until the inspector has FINISHED asking the question£¨Ç§Íò±ðÇÀ´ð£©
Answer ONLY the question asked honestly & directly(Ö»»Ø´ðËùÎÊÎÊÌ⣬ֱ½Ó+³Ïʵ+ÕæÊµ£¬Ç§Íò±ð±à)
Provide documents accurately and timely (5 min.)
Leave room if FDA asks for verbal OK£¨OK! Á¢¼´À뿪£¡£©
Police your area£¨ÄãµÄµØÅÌÀï×öÖ÷£©
Re-read SOP and records£¨²éÔÄSOP/¼Ç¼£©
PRESENT it if you have any document that is seriously close to what is being asked for
(ÈÚ»á¹áͨ£¬Áé»î´¦Ö㬵«±ØÐë»ùÓÚÊÂʵ£¡)
Attempt to clarify or correct misunderstandings
or assumptions£¨¼°Ê±³ÎÇåÎó½â£©
Provide ¡°context¡±  to a SME for any question£¨°ÑÀ´ÁúÈ¥ÂöºÍ¼¼Êõר¼Ò½²Çå³þ£©

¡° I Don¡¯t Know¡± is acceptable
£¨¿ÉÒÔ˵£º±§Ç¸£¬ÎÒ²»ÖªµÀ£¡
¾ø²»ÄÜΪÁËÃæ×Ó±àÔì´ð°¸£¡£©
½±¾ÀÖ
4Â¥2017-09-13 17:45:14
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

lubenle

ÖÁ×ðľ³æ (ÖøÃûдÊÖ)

¡¾´ð°¸¡¿Ó¦Öú»ØÌû

²»Òª×öÒÔÏÂÊÂÇ飡

Volunteer information£¨Ö÷¶¯ÌṩÐÅÏ¢£©
Guess or estimate£¨²Â²â£¬¹À¼Æ£©
Provide any misinformation£¨Ìṩ´íÎóÐÅÏ¢£©
Provide misleading information£¨ÌṩÎóµ¼ÐÅÏ¢£©
Leave Investigator(s) alone£¨Èüì²é¹Ùµ¥Á
Show temper or be argumentative£¨·¢Æ¢Æø£¬Õù±ç£©
NEVER EVER LIE ¾ö²»ÄÜÈö»Ñ£¡
ÈκÎûÓÐÊéÃæÖ¤¾ÝµÄ»Ø´ð¶¼ÊÇ»ÑÑÔ£¡
Don¡¯t show off£¨±ðÂôŪ£¬±ð¶à×죡£©
¾ø²»ÒªÎªÁËÏÔʾ×Ô¼º¶øÖ÷¶¯ÌṩûÓб»Îʵ½µÄÐÅÏ¢£¡
Don¡¯t be shy to ask them to repeat/clarify a question £¨±ðº¦ÐßÈüì²é¹ÙÖØ¸´»ò³ÎÇåÄãûÌýÇåµÄÎÊÌ⣩

±ðÇáÒ×˵¡°²»¡±£¬µ«¾ø²»ÄܱàÔìûÓÐÊéÃæÖ¤¾ÝµÄ´ð°¸£¡
Once you say ¡°NO¡± it¡¯s hard to gain credibility for ¡°YES¡±
Make negative comment about your fellow worker or the company. £¨±ðÔ𱸻ò¸ºÃæÆÀ¼ÛͬÊ»ò¹«Ë¾£¡£©

²»ÒªÔÚ¼ì²é¹ÙÃæÇ°ÒéÂÛ¡¢±È½Ï¡¢ÕùÂÛÎÊÌ⣡

If the inspector is silent don¡¯t panic ¨C just WAIT ¨C DON¡¯T talk
DO NOT have to answer in English
£¨Èç¹ûÄãµÄÓ¢Îıí´ï¿ÉÄÜ»áÒýÆðÎó½â£¬Çë˵ÆÕͨ»°£©

HE may speak/understand Chinese¨C THEY ALL understand body language (¿ÉÄܶ®ººÓ¸ü¶®Ö«ÌåÓïÑÔ£¬ ËùÒÔ²»Òª×öС¶¯×÷£¡)
¡°The huddle ±ð½ôÕÅ/ º¦Å£¬ÄãÓÐÍŶÓÖ§³Ö¡± ¨C they ask a question and five of your guys, go pale and start whispering for a few minutes in frantic tones and then say ¡°yes¡±
Keep your really ¡°enthusiastic¡± guys WELL away from the inspector. £¨±ðÌ«ÈÈÇ飬¸ü±ð×Ô×÷¶àÇ飡£©

¾ø²»ÒªÎªÁËÏÔʾ×Ô¼º¶øÖ÷¶¯ÌṩûÓб»Îʵ½µÄÐÅÏ¢£¡

Don¡¯t do quick fixes
±ð´Ò´Òææ¸ÄÕý£¬Ò»µ©µÝ½»ÉÏÈ¥¾ÍûÓиü¸Ä¿ÉÄÜ£¡
¨C the FDA is not your GMP consultant
¨C You are supposed to be familiar with the regulations

FDA²»ÊÇÎÒÃǵĹËÎÊ£¬±ðÏòËûÇë½Ì·¨¹æÎÊÌ⣡
½±¾ÀÖ
5Â¥2017-09-13 17:47:13
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[¿¼ÑÐ] 327Çóµ÷¼Á +27 Xxjc1107. 2026-04-13 30/1500 2026-04-19 08:22 by cuisz
[¿¼ÑÐ] 294Çóµ÷¼Á +15 µ­È»654321 2026-04-15 15/750 2026-04-19 08:20 by cuisz
[¿¼ÑÐ] 0854Çóµ÷¼Á +23 ÃÅ·ÃþÃþ 2026-04-15 27/1350 2026-04-19 01:59 by ÑÌÓêÁ÷ÑÄ
[¿¼ÑÐ] 291Çóµ÷¼Á +10 ¹ØÒä±±. 2026-04-14 10/500 2026-04-18 23:32 by ·²¡Çé
[¿¼ÑÐ] ÉúÎïѧµ÷¼Á +10 Ö½ÉÈzhishan 2026-04-13 10/500 2026-04-18 21:19 by zqndavala
[¿¼ÑÐ] »¯Ñ§070300 Çóµ÷¼Á +29 ¹þ¹þ¹þ^_^ 2026-04-12 29/1450 2026-04-18 15:56 by Equinoxhua
[¿¼ÑÐ] 297£¬¹¤¿Æµ÷¼Á? +5 ºÓÄÏũҵ´óѧ-ÄÜ 2026-04-14 5/250 2026-04-18 15:17 by Equinoxhua
[¿¼ÑÐ] ÊÕµ½¸´ÊÔµ÷¼Áµ«ÊÇÈ¥²»ÁË +8 СÎÏÅ£* 2026-04-16 8/400 2026-04-18 11:15 by zixin2025
[¿¼ÑÐ] »¯¹¤Ñ§Ë¶294·Ö£¬Çóµ¼Ê¦ÊÕÁô +33 yzyzx 2026-04-12 37/1850 2026-04-17 23:00 by wunaiy88
[¿¼ÑÐ] Çóµ÷¼Á +9 СÄô°®Ñ§Ï° 2026-04-16 11/550 2026-04-17 22:34 by chixmc
[¿¼ÑÐ] Ò»Ö¾Ô¸»ªÖÐũҵ071010£¬320Çóµ÷¼Á +17 À§À§À§À§À¤À¤ 2026-04-14 19/950 2026-04-17 20:08 by ¹ØÒ»ÕµµÆcd
[¿¼ÑÐ] 297£¬¹¤¿Æµ÷¼Á?ºÓÄÏũҵ´óѧ±¾¿Æ +14 ºÓÄÏũҵ´óѧ-ÄÜ 2026-04-14 14/700 2026-04-16 14:41 by dingyanbo1
[¿¼²©] É격×Ô¼ö +3 LinxiaÁÖÏÄ 2026-04-13 3/150 2026-04-16 12:55 by Ä«ºÉ֮¶
[¿¼ÑÐ] 085404 22408 309·ÖÇóµ÷¼Á +9 lzmk 2026-04-14 10/500 2026-04-15 20:02 by ѧԱJpLReM
[¿¼ÑÐ] 0854µ÷¼Á +13 ³¤¹­°Á 2026-04-12 16/800 2026-04-15 13:45 by fenglj492
[¿¼ÑÐ] 085801µçÆø×¨Ë¶272Çóµ÷¼Á +19 µçÆøÀî 2026-04-13 21/1050 2026-04-15 13:37 by ºÚ¿Æ¼¼¿óÒµ
[½Ìʦ֮¼Ò] ת³¤Æ¸ÁË +7 ¼òµ¥»¯xn 2026-04-13 7/350 2026-04-14 14:50 by xindong
[¿¼ÑÐ] Çóµ÷¼Á +12 ºÎÆøÕý 2026-04-13 13/650 2026-04-14 14:47 by zs92450
[¿¼ÑÐ] Çóµ÷¼Á +3 ÎÒ°®¸ßÊý¸ßÊý°®Î 2026-04-12 3/150 2026-04-14 01:00 by Íõ¬Bè±
[¿¼ÑÐ] 297¹¤¿Æ£¬Çóµ÷¼Á? +13 ºÓÄÏũҵ´óѧ-ÄÜ 2026-04-12 13/650 2026-04-13 14:12 by dingyanbo1
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û