for cause audit x directed audit or inspection

Czech translation: nařízený audit/kontrola

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:for cause audit x directed audit or inspection
Czech translation:nařízený audit/kontrola
Entered by: Lenka Havrdova

13:39 May 21, 2014
English to Czech translations [PRO]
Medical - Law: Contract(s) / regulatory actions
English term or phrase: for cause audit x directed audit or inspection
A significant issue for a drug manufacturer:

Initiation of a directed or for cause regulatory inspection.
Lenka Havrdova
Local time: 01:55
nařízený audit/kontrola
Explanation:
To "or" je zde použito ve smyslu "neboli"

http://www.medicinapropraxi.cz/pdfs/med/2014/01/10.pdf
Podle kauzality se audity dělí na rutinní audity, které jsou předem naplánovány, dále nařízené audity (anglicky »For Cause« neboli directed audit), které probíhají při podezření z non-compliance či podvodu, a předinspekční audity před hlášenou inspekcí regulační autority.

http://www.ecohsr.pitt.edu/activities-services/audits.php
http://www.hopkinsmedicine.org/institutional_review_board/ab...


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Note added at 17 hrs (2014-05-22 07:01:22 GMT)
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
FDA's inspection programs include two types of assignments: routine inspections and directed inspections (sometimes termed "for cause").

http://www.challiance.org/Academics/QualityAssuranceQualityI...
A “for cause,” or directed, audit is a review that is usually initiated at the request of the IRB, the Institution, or another oversight body.
A “not-for cause,” or routine, audit is a service CHA provides to its researchers that is performed on a random basis and is conducted as part of overall effort to assure and/or improve the quality of research conducted at CHA.

http://researchadmin.iu.edu/CRCO/crco_audits.html
For-cause (directed)
Not-for-cause (scheduled)
Selected response from:

Ing. Petr Bajer
Czech Republic
Local time: 01:55
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1nařízený audit/kontrola
Ing. Petr Bajer


  

Answers


17 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
nařízený audit/kontrola


Explanation:
To "or" je zde použito ve smyslu "neboli"

http://www.medicinapropraxi.cz/pdfs/med/2014/01/10.pdf
Podle kauzality se audity dělí na rutinní audity, které jsou předem naplánovány, dále nařízené audity (anglicky »For Cause« neboli directed audit), které probíhají při podezření z non-compliance či podvodu, a předinspekční audity před hlášenou inspekcí regulační autority.

http://www.ecohsr.pitt.edu/activities-services/audits.php
http://www.hopkinsmedicine.org/institutional_review_board/ab...


--------------------------------------------------
Note added at 17 hrs (2014-05-22 07:01:22 GMT)
--------------------------------------------------

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
FDA's inspection programs include two types of assignments: routine inspections and directed inspections (sometimes termed "for cause").

http://www.challiance.org/Academics/QualityAssuranceQualityI...
A “for cause,” or directed, audit is a review that is usually initiated at the request of the IRB, the Institution, or another oversight body.
A “not-for cause,” or routine, audit is a service CHA provides to its researchers that is performed on a random basis and is conducted as part of overall effort to assure and/or improve the quality of research conducted at CHA.

http://researchadmin.iu.edu/CRCO/crco_audits.html
For-cause (directed)
Not-for-cause (scheduled)

Ing. Petr Bajer
Czech Republic
Local time: 01:55
Native speaker of: Native in CzechCzech
PRO pts in category: 18

Peer comments on this answer (and responses from the answerer)
agree  Mandelik
3 hrs
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