Qlt

Quality

– Risk management approach in the organization
– Deployment of regulatory and quality GxP requirements
– Implementation of processes, process mapping
– Writing of quality documents

– Continuity of implemented activities: establishment of the quality plan
– Management of quality documentation
– Management of quality systems and processes
– Updating of quality documents

– Internal/external audits
– System audits/procedures
– Preparation for site inspections (FDA, ANSM, etc.)

– Optimization of activities (lean management : formalization of objectives, evaluation of activities, identification of problems, identification of causes, resolution of problems)

– Qualitative (revision of ICSRs) and quantitative (statistical analysis in databases) detection of signals
– Validation and evaluation of signals identified during vigilance activities
– Definition of possible measures to minimize the risks associated with signals
– Communicate immediately to the authorities the signals that may have repercussions on public health and the benefit-risk balance of the products in question

– Validation et évaluation des signaux identifiés lors des activités de vigilance
– Définition des mesures possibles pour minimiser les risques associés aux signaux
– Communiquer immédiatement aux autorités les signaux qui peuvent avoir des répercussions sur la santé publique et le profil bénéfice-risque des produits en question

– Establishment of training materials specific to needs (according to different standards)

– Regulatory and standards monitoring

– Management of Change Control, deviations, non-conformities, CAPA

– Quality risk assessment
– ​​Carrying out risk analyzes based on pharmaceutical regulations and recognized guides.

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