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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(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

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浼氳鏃ョ▼錛?/span>

09:00-09:15

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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

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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

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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 

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> 

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