Cristina Forzani

CAPA management and NC processes KPI definition Reporting and controlling: documentation, due dates, effectivity Continual improvement and development of CAPA system Project management in Quality EN ISO 13485: 2016 93/42/EEC (MDD) 2017/745/EU (MDR) FDA 21 CFR 820, FDA 21 CFR 803, FDA 21 CFR 806 MEDDEV 2 12-1 ISO 14971

ISO 13485:2016, ISO 9001:2015, 21 CFR part 820 Internal, customer, supplier, ISO, FDA Audis Continuous improvement of quality processes Deviation management: root cause analysis, CAPAs and effectiveness proof, change management Documentation release and trainings Data trending for Quality data incl. Hygiene/Microbiology and relative corrective actions HYGIENE OFFICER Hygiene and microbiology monitoring, hygiene processes and hygiene definition

Clean room production (ISO class 8) Product Mater File: Change management, compliance with specifications and technical drawings, validations and qualifications (OQ, PQ of Injection molding machines and tools, assembly lines). ISO 13485:2016, ISO 9001:2015, 21 CFR part 820 Internal, customer and supplier complaints, CAPA, ISO-, Customer- and FDA-Audits, product batch release. Documentation und Personnel training, creation of SOP, Inspection specifications and inspection plans.

Export and logistics, QA, laboratory management

Lab organization, purchasing and warehousing