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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)
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Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
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11K
Jan 2, 2012
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
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13K
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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12K
Oct 18, 2009
Marc
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21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
Scott Catron
Apr 22, 2008
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15K
Apr 22, 2008
Scott Catron
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
Scott Catron
Apr 22, 2008
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29K
Apr 22, 2008
Scott Catron
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The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization?
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Is my company responsible for enforcing good documentation practices on supplier COA?
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Does the CFR require minimum frequency for QMS audits?
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