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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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0
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10,181
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
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12,332
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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10,737
Oct 18, 2009
Marc
Sticky
21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
Scott Catron
Apr 22, 2008
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13,471
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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28,098
Apr 22, 2008
Scott Catron
Discussions
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Non_GMP (PIC/S 010) production in a GMP area ?
John_Shepard
Dec 23, 2022
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630
Dec 23, 2022
John_Shepard
M
DHF for drug products
Mr. E
Nov 4, 2022
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449
Nov 4, 2022
Mr. E
N
Generic Rework/Reprocessing Procedure
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Oct 16, 2018
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3
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4,316
Oct 25, 2022
v9991
E
The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization?
Emily 1113
Sep 21, 2022
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537
Sep 21, 2022
Emily 1113
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Health Authority Inspections
QuinnM
Sep 19, 2022
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355
Sep 19, 2022
QuinnM
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Validation Methods of Machine learning and Artificial intelligence
patilrahuld
Aug 10, 2022
2
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10
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962
Aug 26, 2022
QuinnM
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Pharmaceuticals and Manufacturing
Kaosfit13
Jul 26, 2022
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488
Jul 26, 2022
Kaosfit13
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Parabiotics on the US market
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Jun 9, 2022
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3
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663
Jun 10, 2022
Zero_yield
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Daily QA Inprocess observation
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Jun 2, 2022
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687
Jun 3, 2022
bengr16
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END CALIBRATION CANNOT BE PERFORMED
khamid1963
May 24, 2022
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627
May 25, 2022
Ron Rompen
21 CFR Part 11 - Steps to take if we want to validate an electronic system
Anonymous16-2
Aug 4, 2020
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2,177
May 21, 2022
Alex Kennedy
I
Hold Time studies for Primary Reference standards
Idris
May 5, 2022
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611
May 5, 2022
Idris
D
Verify Audit Trail of SaaS system
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Sep 16, 2021
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Apr 4, 2022
yodon
S
NC and Deviation approach - please help
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Nov 12, 2021
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Jim Wynne
A
Reduced Testing of Pharmaceutical Raw Materials
AAA211
Jun 11, 2019
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3
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2,518
Nov 4, 2021
Satyakumarreddy
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