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Volume III - 5.8 Helpful References Pages on the Internet or Intranet

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-05

VERSION NO.:1.5

Section 5 - Analysts on Inspection

EFFECTIVE DATE: 10/01/2003REVISED: 01-30-13

ORA Inspection References
http://www.fda.gov/ora/inspect_ref/default.htm

Weblern 
http://inside.fda.gov:9003/Library/default.htm (link to the USP, EP, JP, PDR, and other publications)

Investigations Operations Manual
http://www.fda.gov/ICECI/Inspections/IOM/default.htm (link to the IOM)

21 CFR Part 11
http://www.21cfrpart11.com/

CDER Guidance Page
http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm (link Inspection Guides)

CVM Guidance Page
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm

(link to CVM Guidance Documents)
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ GuidanceforIndustry/ucm123633.htm
(BSE inspections)

CFSAN Guidance Page
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/default.htm(link to CFSAN Guidance Documents)

CBER Guidance Page 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
(link to CBER Guidance Documents)

CDRH Guidance Page
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

(link to CDRH Guidance Documents)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ QualitySystemsRegulations/default.htm
(link to CDRH Quality Systems Documents)

International Conference on Harmonization (ICH) Homepage
http://www.ich.org/

Veterinary International Conference on Harmonization (VICH) Homepage
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122050.htm
http://www.fda.gov/RegulatoryInformation/default.htm (Regulatory Information)

Product Code Builder
http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfm

TurboEIR
https://oeapps.ora.fda.gov/turboeir/    (TurboEIR Webpage)