Video: FDA CFR 21 yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Title 21 yog ib feem ntawm Txoj Cai Tswjfwm Ntiag Tug uas tswj cov zaub mov thiab tshuaj hauv Tebchaws Meskas rau Food and Drug Administration ( FDA ), Lub Tsev Haujlwm Saib Xyuas Tshuaj Yeeb Tshuaj (DEA), thiab Lub Chaw Haujlwm Saib Xyuas Kev Ruaj Ntseg Hauv Tebchaws (ONDCP).
Hauv qhov no, 21 CFR sawv rau dab tsi?
Txoj Cai ntawm Tsoom Fwv Txoj Cai
Ib tug kuj yuav nug, 21 CFR Part 11 yuav tsum yog dab tsi? FDA 21 CFR Tshooj 11 ua raws txoj cai hais tias cov tuam txhab uas siv cov tshuab hluav taws xob rau cov ntaub ntawv thiab kev kos npe yuav tsum muaj kev lees paub tias cov ntaub ntawv hluav taws xob yog qhov tseeb. Cov kev cai tag nrho qhia qhov tsim nyog ntawm kev ceev ntiag tug ntawm cov ntaub ntawv hluav taws xob.
Kuj nug, tshooj twg ntawm 21 CFR muaj cov cai los ntawm FDA?
Title 21 CFR Nws Part 11 yog ib feem ntawm Title 21 ntawm Code of Federal Kev cai uas tsim tsa Tsoomfwv Meskas Cov Khoom Noj thiab Tshuaj ( FDA ) cov kev cai ntawm cov ntaub ntawv hluav taws xob thiab kos npe hluav taws xob (ERES).
Koj hais txog CFR 21 li cas?
Ntaus tus naj npawb ntawm cov kev cai, tom qab ntawd cov ntawv luv " C. F. R ."Ntaus ib qhov chaw, tom qab ntawv ntaus cim cim (§), qhov chaw, thiab tus lej ntawm ntu. Kaw koj siv nrog lub xyoo tshiab ntawm lub CFR . Ntaus qhov chaw tom qab tus lej ntu, tom qab ntawv ntaus lub xyoo CFR tsab ntawv nyob rau hauv kab lus.
Pom zoo:
Dab tsi yog bureaucracy thiab nws cov haujlwm yog dab tsi?
Cov haujlwm ntawm Tsoom Fwv Teb Chaws Bureaucracy. Tsoom fwv teb chaws bureaucracy ua peb lub luag haujlwm tseem ceeb hauv tsoomfwv: kev siv, kev tswj hwm, thiab kev tswj hwm. Kev ua haujlwm niaj hnub ntawm bureaucracy - sau nqi, muab ntawv tso cai, muab xeem, thiab ntxiv rau - yog kev tswj hwm ntawm nws lub hom phiaj
Dab tsi yog rau lub tshuab yooj yim thiab cov piv txwv ntawm lawv yog dab tsi?
Cov no yog rau lub tshuab yooj yim: cov nplais, lub log thiab lub qag, qib, lub dav hlau inclined, ntsia hlau, thiab lub log
CFR hauv FDA yog dab tsi?
Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai (CFR) yog ib codification ntawm cov kev cai dav dav thiab mus tas li luam tawm nyob rau hauv Tsoom Fwv Teb Chaws Sau Npe los ntawm Cov Thawj Coj thiab cov koom haum ntawm Tsoom Fwv Teb Chaws.. Title 21 ntawm CFR yog tshwj tseg rau cov cai ntawm Food and Drug Administration
Qhov txawv ntawm CFR thiab CNF yog dab tsi?
C&F, CNF lossis CFR txhais tau tias Tus Nqi & Freight. Ntawm no, tus nqi muag khoom ntawm kev muag khoom suav nrog tus nqi thiab freight ntawm cov khoom. Kuv yuav piav qhia txog CFR (tseem hu ua CNF thiab C&F) cov ntsiab lus ntawm kev xa khoom nrog piv txwv yooj yim. Kev tuav pov hwm ntawm cov khoom tau ntsib los ntawm tus neeg yuav khoom hauv caseof C&F kev lag luam
21 CFR Pharma yog dab tsi?
21 CFR thiab Nws Cov Lus Pom Zoo. Title 21 ntawm CFR los yog Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai cuam tshuam nrog kev tswj hwm cov zaub mov thiab tshuaj hauv Tebchaws Meskas rau peb ntawm nws cov kev tswj hwm: FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) thiab ONDCP (Office of National. Txoj Cai Tswj Xyuas Tshuaj)