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(qiáng)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(jiǎng)鍝嶈嵂鐗╅噴鏀撅紝鐢熺墿鍒╃敤搴﹀強(qiáng)閰嶆柟紼沖畾鎬х殑閲嶈鍥犵礌錛屾洿鎴愪負(fù)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?jìng)鍦哄噯鍏ョ殑闂ㄦ鍜屽繀瑕佹潯錃g銆?/span>
涓轟簡(jiǎn)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(jiǎn)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(qiáng)鏂規(guī)硶楠岃瘉鐮旇浼?xì)鈥?/span>銆傚眾鏃訛紝涓嫳涓ゅ浗涓撳灝嗗湪浼?xì)璁幇鍦哄仛绮惧僵鎶ュ憡銆傛垜浠瘹閭�(gè)鎮(zhèn)ㄨ巺涓村弬浼?xì)锛?/span>
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(xì)璇︾粏鍦板潃鏀跺埌鎶ュ悕鍥炴墽鍚庝簬浼?xì)鍓嶄竴鍛ㄥ彟琛岄偖浠墮�氱煡錛?/span>
浼?xì)璁棩绋?/span>錛?/span>
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09:00-09:15 |
絳懼埌 |
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09:15-10:30 |
鑽墿棰楃矑琛ㄥ緛鎶�鏈強(qiáng)鍏跺湪鍒惰嵂棰嗗煙鐨勫簲鐢?/span> |
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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(qiáng)鍒嗘瀽鏂規(guī)硶楠岃瘉 |
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12:15-13:30 |
宸ヤ綔鍗堥 |
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13:30-14:30 |
IQ/OQ/PQ鍙?qiáng)鍏惰瘉涔︾殑鏈夋晥鎬?/span> |
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14:30-14:45 |
鑼舵瓏 |
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14:45-15:45 |
FDA 21CFR part 11鐢?shù)瀛惤{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?qiáng)绛旂?/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(xì)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(xì)鍥炴墽鍚庡Q屽競(jìng)鍦洪儴宸ヤ綔浜哄憳灝嗕細(xì)浜庝細(xì)鍓嶄竴鍛ㄩ偖浠墮�氱煡鎮(zhèn)ㄧ爺璁ㄤ細(xì)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(xì)椹皵鏂囧叕鍙稿競(jìng)鍦洪儴錛屽懆灝忓錛?span>021-80137013
娉細(xì)鏈浼?xì)璁笉鏀跺彇鋼Q浣曞弬浼?xì)璐瑰Q屽茍鎻愪緵浼?xì)璁祫鏂欏拰宸ヤ綔鍗垬锛屼氦閫氫綇瀹塊渶鑷悊銆?/span>