Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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END CALIBRATION CANNOT BE PERFORMED
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2
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Ron Rompen
Ron Rompen
Anonymous16-2
21 CFR Part 11 - Steps to take if we want to validate an electronic system
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3
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Alex Kennedy
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Hold Time studies for Primary Reference standards
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0
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865
Idris
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Verify Audit Trail of SaaS system
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5
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yodon
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NC and Deviation approach - please help
2
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12
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Jim Wynne
Jim Wynne
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Reduced Testing of Pharmaceutical Raw Materials
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3
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Satyakumarreddy
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Equivalent role of QP (Qualified Person) in FDA Regulations
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9
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pbojsen
pbojsen
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Pharmaceutical Shelf Life Testing
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0
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827
Sarahb333
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Static Mixer on Solution production Mixer
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0
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791
ifserav
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211, subpart B, section 211.22 as it applies to pharma printing
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3
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indubioush
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Javier Guan
Water requirement for Non-sterile topical OTCs
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0
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Javier Guan
Javier Guan
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New Facility register with FDA
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4
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William55401
William55401
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Sterilized components shelf life
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1
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planB
planB
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ISO 9001:2015 vs 21 CFR Part 211 matrix
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sdedonder
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Comparison wanted: ISO 15378:2018 vs. PS9000:2016
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katinkaszekeres
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