{"id":776,"date":"2019-10-08T22:26:01","date_gmt":"2019-10-08T20:26:01","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=776"},"modified":"2019-10-27T23:06:32","modified_gmt":"2019-10-27T22:06:32","slug":"procesvalidering","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/services\/quality-management-goer-tingene-rigtigt\/procesvalidering\/","title":{"rendered":"Procesvalidering"},"content":{"rendered":"
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\n\t\t\"Procesvalidering\"\n\t<\/div>\n\n<\/div><\/div><\/div><\/div>
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Procesvalidering<\/h2>\n

Jeg har en solid erfaring med validering af processer i henhold til kravene i ISO 15378, ISO 13485, 21 CFR part 820, GMP (Good Manufacturing Practices) samt GHTF \u2013 Process Validation Guidance.<\/p>\n

Min erfaring d\u00e6kker alle trin i valideringsprocessen:<\/p>\n

DQ \u2013 Design Qualification<\/p>\n

IQ \u2013 Installation Qualification<\/p>\n

OQ \u2013 Operational Qualification<\/p>\n

PQ \u2013 Performance Qualification<\/p>\n

Efter mange \u00e5r indenfor plastindustrien med produktion af prim\u00e6r emballage til medicin, har jeg s\u00e6rlig stor erfaring med validering af spr\u00f8jte- og bl\u00e6sest\u00f8bning af plastemner (injection moulding, injection blow moulding & blow moulding) samt fylde- og samleprocesser.<\/p>\n

I mit virke som konsulent, har jeg hjulpet sm\u00e5 som store virksomheder med at etablere eller optimere deres proces for validering af s\u00e5vel interne processer som processer lagt ud til underleverand\u00f8rer. Jeg har desuden gennemf\u00f8rt undervisning af medarbejdere i kvalitet, produktion og R&D.<\/p>\n

For at kunne have en risikobaseret tilgang til procesvalidering, har jeg ligeledes hjulpet virksomheder med at lave risikostyring<\/a> (risk management) af deres og deres underleverand\u00f8rers processer ved brug af FMEA (Failure Mode & Effect Analysis).<\/p>\n

Jeg har desuden hjulpet kunder med at definere kravene til URS (User Requirements Specification) samt udarbejde procedure for software validering.<\/a><\/p>\n

 <\/p>\n

Relevante links:<\/p>\n

21 CFR part 820:\u00a0https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=820.75<\/a><\/p>\n

GHTS \u2013 Process Validation Guidance:\u00a0http:\/\/www.imdrf.org\/docs\/ghtf\/final\/sg3\/technical-docs\/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf<\/a><\/p>\n

Medical Device Regulation:\u00a0https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:02017R0745-20170505<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

Procesvalidering Jeg har en solid erfaring med validering af processer i henhold til kravene i ISO 15378, ISO 13485, 21 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":654,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-776","page","type-page","status-publish","hentry"],"yoast_head":"\nProcesvalidering - Borgensgaard Consulting<\/title>\n<meta name=\"description\" content=\"Jeg har en solid erfaring med procesvalidering i henhold til kravene i ISO 15378, ISO 13485, 21 CFR part 820, GMP (Good Manufacturing Practices) samt GHTF \u2013 Process Validation Guidance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/borgensgaard-consulting.dk\/da\/services\/quality-management-goer-tingene-rigtigt\/procesvalidering\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Procesvalidering - 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