Sign in to save your progress, vote, and build your own decks.Sign in
FDA Terms
36 cards·by filbi74
Form FDA 483 (or 483)
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR 820
Also known as the Quality System Regulation (QSR) outlines, Current Good Manufacturing
Practice (CGMP) regulations that govern the methods u
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
21 CFR 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Human Food.
21 CFR 56
Institutional Review Boards (IRB). Applicable to clinical trials guidelines.
21 CFR 312
Investigational New Drug Application. Contains procedures governing the use of
investigational new products including the submission to, and
483
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR 820
Also known as the Quality System Regulation (QSR) outlines, Current Good Manufacturing
Practice (CGMP) regulations that govern the methods u
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
21 CFR 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Human Food.
21 CFR 56
Institutional Review Boards (IRB). Applicable to clinical trials guidelines.
21 CFR 312
Investigational New Drug Application. Contains procedures governing the use of
investigational new products including the submission to, and
483
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR 820
Also known as the Quality System Regulation (QSR) outlines, Current Good Manufacturing
Practice (CGMP) regulations that govern the methods u
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
21 CFR 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Human Food.
21 CFR 56
Institutional Review Boards (IRB). Applicable to clinical trials guidelines.
21 CFR 312
Investigational New Drug Application. Contains procedures governing the use of
investigational new products including the submission to, and
483
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR 820
Also known as the Quality System Regulation (QSR) outlines, Current Good Manufacturing
Practice (CGMP) regulations that govern the methods u
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
21 CFR 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Human Food.
21 CFR 56
Institutional Review Boards (IRB). Applicable to clinical trials guidelines.
21 CFR 312
Investigational New Drug Application. Contains procedures governing the use of
investigational new products including the submission to, and
483
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.
21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR 820
Also known as the Quality System Regulation (QSR) outlines, Current Good Manufacturing
Practice (CGMP) regulations that govern the methods u
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
21 CFR 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls
for Human Food.
21 CFR 56
Institutional Review Boards (IRB). Applicable to clinical trials guidelines.
21 CFR 312
Investigational New Drug Application. Contains procedures governing the use of
investigational new products including the submission to, and
483
Document and communicate concerns discovered during an inspection--do not represent a
final Agency determination regarding compliance.