FDA CFR 21 yog dab tsi?
FDA CFR 21 yog dab tsi?

Video: FDA CFR 21 yog dab tsi?

Video: FDA CFR 21 yog dab tsi?
Video: 21 CFR! FDA США! Базовые знания. # 21CFR # ФАРМАЦЕВТИЧЕСКАЯ ПРОМЫШЛЕННОСТЬ # USFDA # 21CFR ЧАСТЬ 211. 2024, Kaum ib hlis
Anonim

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.

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