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涓轟簡娣卞叆鎺㈣棰楃矑琛ㄥ緛鎶�鏈湪鑽墿棰嗗煙鐨勫簲鐢紝甯姪涓浗鍖昏嵂浼佷笟鍜岀爺鍙戞満鏋勪簡瑙ｅ浣曞緩绔嬪拰瀹屾垚絎﹀悎FDA絳夋硶瑙勭殑鏂規硶楠岃瘉鍜?/span>IQ/OQ/PQ璇佹槑鏂囦歡錛岀悊瑙?/span>FDA 21CFR 11鐢靛瓙絳懼悕鍜岀數瀛愯褰曡绔狅紝鑻卞浗椹皵鏂囦華鍣ㄦ湁闄愬叕鍙稿皢浜?span>2014騫?/span>5鏈?/span>29鏃ュ湪嫻峰彛涓懼姙鈥滆嵂鐗╅綺掕〃寰佸強鏂規硶楠岃瘉鐮旇浼氣�?/span>銆傚眾鏃訛紝涓嫳涓ゅ浗涓撳灝嗗湪浼氳鐜板満鍋氱簿褰╂姤鍛娿�傛垜浠瘹閭�鎮ㄨ巺涓村弬浼氾紒
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2014騫?/span>5鏈?/span>29鏃?nbsp;鏄熸湡鍥?nbsp;嫻峰彛
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浼氳鏃ョ▼錛?/span>
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09:00-09:15 |
絳懼埌 |
|
09:15-10:30 |
鑽墿棰楃矑琛ㄥ緛鎶�鏈強鍏跺湪鍒惰嵂棰嗗煙鐨勫簲鐢?/span> |
|
10:30-10:45 |
鑼舵瓏 |
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10:45-12:15 |
褰卞搷鑽墿綺掑害嫻嬮噺緇撴灉鐨勫洜绱犲強鍒嗘瀽鏂規硶楠岃瘉 |
|
12:15-13:30 |
宸ヤ綔鍗堥 |
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13:30-14:30 |
IQ/OQ/PQ鍙婂叾璇佷功鐨勬湁鏁堟�?/span> |
|
14:30-14:45 |
鑼舵瓏 |
|
14:45-15:45 |
FDA 21CFR part 11鐢靛瓙絳懼悕鎺у埗娉曡瑙ｆ瀽 |
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15:45:16:30 |
鐜板満浜ゆ祦鍙婄瓟鐤?/span> |
(IQ錛?/span>Installation Qualification OQ錛?/span>Operational Qualification PQ錛?/span>Performance
Qualification)
鎶ュ悕鏂瑰紡錛?/span>
璇鋒偍瀹屾暣濉啓鍙備細鍥炴墽錛屽彂閫侀偖浠惰嚦錛?/span>wendy.zhou@malvern.com.cn錛涙敹鍒版偍鐨勫弬浼氬洖鎵у悗錛屽競鍦洪儴宸ヤ綔浜哄憳灝嗕細浜庝細鍓嶄竴鍛ㄩ偖浠墮�氱煡鎮ㄧ爺璁ㄤ細涓懼姙鐨勮緇嗗湴鍧�銆?/span>
濡傛偍鏈変換浣曢棶棰橈紝璇瘋仈緋伙細椹皵鏂囧叕鍙稿競鍦洪儴錛屽懆灝忓錛?span>021-80137013
娉細鏈浼氳涓嶆敹鍙栦換浣曞弬浼氳垂錛屽茍鎻愪緵浼氳璧勬枡鍜屽伐浣滃崍槨愶紝浜ら�氫綇瀹塊渶鑷悊銆?/span>