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Searching Content indexed under Compliance by Frederick Ball ordered by Published Date Descending.
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FDA Issues Final Guidance On Data Integrity And Compliance With Drug CGMP
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate.
United States
18 Jan 2019
2
FDA Announces New UDI Compliance Deadlines Via Another Guidance Document
On September 24, 2013, the Food and Drug Administration (FDA) issued a "final" rule regarding the Unique Device Identification System to adequately identify devices through distribution and use
United States
4 Jan 2019
3
CDER's New MAPP On Risk-Based Site Selection Model For Routine Inspections
The list is developed from inputting sites from CDER's Catalog of Manufacturing Sites into the SSM
United States
15 Nov 2018
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