Torben Kristensen Email & Phone Number

Tasks:Internal and external auditsCAPAsStandards and regulation reviewWriting/reviewing SOP'sResults:Input for process revisions.Streamlining audit process Operating procedures reviewed and new processes implemented.

Hvidovre, Hovedstaden, Danmark

Tasks:Batch releaseHandling deviationsAuditing (internal/supplier)Handling/reviewing change requestsWriting/reviewing SOP'sQualification/Validation of equipmentResults:Improvement to the flow of batch release.Input for process revisions.Operating procedures reviewed and new processes implemented.

Glostrup

Tasks:Complaint handlingWriting/reviewing SOP'sCAPAResults:Complaint backlog reducedStreamlining of complaint handlingOperating procedures reviewed and streamlined

Måløv

Tasks:Auditing (internal/supplier)Batch releaseComplaint investigationHandling/reviewing change requestsWriting/reviewing SOP'sResults:Complaint investigation and reporting has been updated and streamlined.Input for process revisions.Operating procedures reviewed and new processes implemented.

Humlebaek

Tasks:Complaint handlingReporting to authoritiesRevision of processesResults:Registration of complaints in databaseDrafting Reports to authorities and other relevant partiesCommunication with internal and external partnersInput for process revision

Danish Health And Medicines Authority

Tasks:Case handling (FSCA, NCAR, Vigilance reports)Communication of legislation to manufacturers, citizens and other interested partiesParticipation in various working groupsResults:Advising on classification on Medical devicesDrafting proposal for international working party in relations to reporting on incidents and corrective actions

Herlev

Tasks:Production of capillary tubes/pipettesQuality control of products.Weight check of tubesProduction of Blood-gas tubes (Heparin)Results:Input for improvement of SOP's and workflow

Skovlunde

Tasks:Responsible for the drawing up of a quality manualCertification of the clean-room in accordance to DS/EN 9001 and 14644Training of staffHandling non-conformity rapportsConducting internal auditsParticipate in the daily productionResults:Quality manual compiledClean-room was certified in 2005 and since been re-certified on the basis of the quality manualStaff was trained uniformly and new internal courses were started

Tasks:Species identification (Polychaeta, Crustacea, Mollusca)Maintenance of species database of marine invertebratesConstruction of a reference collectionResults:Database was updated in accordance to recent researchReference collection was started and old reference species was revised

Tasks:Maintenance of collectionHandling of loans of material (in/out)Responsible for the mapping of Polychaeta in the waters around GreenlandLiterature studiesSpecies identificationResults:Several lost samples were located and returned to the collectionNew material was added to the collectionThe marine fauna of Greenland was mapped

Tasks:Maintenance of species database of marine invertebratesAiding M.Sc. students with the identification of speciesResults:Database was revised and updated

Workshop In Thailand

Tasks:Collection of materialSpecies identificationOrganization of excursions and field trip for the invited scientistsResults:Potentially new species were isolatedNew material added to the collectionThe workshop proceeded to everybody’s satisfaction