Food and Drug (Pharmaceuticals) related Regulations

US Food and Drug Administration (FDA)

All topics connected with the US Food and Drug Administration (FDA), a division of the United States Department of Health and Human Services covering CDER, CBER, CDRH, CFSAN, CVM, NCTR, ORA and OC divisions.
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FDA requirements for risk analysis
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Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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255
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Discussion Threads
255
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1,115
Non_GMP (PIC/S 010) production in a GMP area ?

Qualification and Validation (including 21 CFR Part 11)

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Discussion Threads
383
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Alternate solution to validate Excel Spreadsheets
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