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闅忕潃鍖昏嵂宸ヤ笟鐨勯閫熷彂灞曪紝瓚婃潵瓚婂鐨?/span>鍖昏嵂浼佷笟姝f姇鍏ュぇ閲忚祫婧愯繘琛屾柊鑽爺鍙戝強浜у搧鐨勮川閲忔帶鍒訛紝鑰岃嵂鐗╃殑綺掑害鍒嗗竷鍜岄綺掑艦鎬佹鏄獎鍝嶈嵂鐗╅噴鏀撅紝鐢熺墿鍒╃敤搴﹀強閰嶆柟紼沖畾鎬х殑閲嶈鍥犵礌錛屾洿鎴愪負鍘熸枡鑽拰鍒跺墏絳夊尰鑽駭鍝佺殑蹇呮祴鍙傛暟銆傚悓鏃訛紝鐢變簬鍖昏嵂琛屼笟鐨勭壒孌婃ц川錛?span>FDA鍜?/span>GMP璁よ瘉宸叉垚涓哄尰鑽駭鍝佸嚭鍙f垨甯傚満鍑嗗叆鐨勯棬妲涘拰蹇呰鏉′歡銆?/span>
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(guī)硶楠岃瘉鍜?/span>IQ/OQ/PQ璇佹槑鏂囦歡錛岀悊瑙?/span>FDA 21CFR 11鐢?shù)瀛惤{懼悕鍜岀數(shù)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(guī)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(zhèn)ㄨ巺涓村弬浼氾紒
鏃墮棿鍦扮偣錛?/span>
2014騫?/span>5鏈?/span>29鏃?nbsp;鏄熸湡鍥?nbsp;嫻峰彛
錛堟敞錛氱爺璁ㄤ細璇︾粏鍦板潃鏀跺埌鎶ュ悕鍥炴墽鍚庝簬浼氬墠涓鍛ㄥ彟琛岄偖浠墮氱煡錛?/span>
浼氳鏃ョ▼錛?/span>
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 |
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(guī)硶楠岃瘉 |
12:15-13:30 |
宸ヤ綔鍗堥 |
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?shù)瀛惤{懼悕鎺у埗娉曡瑙f瀽 |
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?zhèn)ㄧ殑鍙備細鍥炴墽鍚庡Q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(zhèn)ㄧ爺璁ㄤ細涓懼姙鐨勮緇嗗湴鍧銆?/span>
濡傛?zhèn)ㄦ湁鋼Q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>