PPT-Guidance Document for writing NC

How to write correct NCs What is a nonconformity In terms of an audit a nonconformity is any time you find evidence that a process has not been performed as it was planned and in accordance with the requirements from the standard The intent of the audit is to compare the planned arrangements of the process against what is actually happening and verifying that the practices being used conform to what is planned In short we expect compliance when we audit but when we find evidence that this is not the case we have identified a nonconformity. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER January 2010 Clinical Medical brPage 2br Guidance for Industry Assessment of Abuse Potential of Dr 3 1 Research ethics committee approval3 2 Grounds for objection 4 3 Labelling of medical devices 100 Purpose All circulars 200 101 Applicability All circulars 200 102 Exceptions 110 200 103 Authorities All circulars 200 104 Supersession All circulars 200 105 Effect On Other Issuances Revised 200 106 Agency Implementation Revised 200 107 OMB Resp com . SYFTET. Göteborgs universitet ska skapa en modern, lättanvänd och . effektiv webbmiljö med fokus på användarnas förväntningar.. 1. 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