CURRICULUM VITAE of Alice Ravizza Via Mazzini 42, 10123 Torino Phone +39 011 6606310 Mobile +39 349 3621829 Email [email protected] P.Iva 10744710012 Personal data Place and date of birth: Basel (Switzerland), December 18, 1979 Citizenship: Italian Fellow Engineer at “Ordine degli Ingegneri della Provincia di Torino” Married, three children born July 2006, February 2008 and December 2011 Held Courses • • • • • • 26 November 2013 At Bioindustry Park Silvano Fumero: “Design control, progettazione in ambito GMP per compliance FDA”. In Italian 11 June 2013 At Skillab Skillab S.r.l. centro valorizzazione risorse umane Presso Unione Industriali Torino “Prodotti delle start-up e Marcatura CE”. In Italian. 12 April 12th and May 10th, 2013 At Politecnico di Milano, esercitazioni del corso Progettazione di Sistemi di Supporto alla Vita course “Medical devices design: from the laboratory to the production department”. In English and Italian. April 22nd and April 29th, 2013 At Dottorato in Tecnologie applicate alle scienze chirurgiche, , Università di Medicina e Chirurgia, Torino, course “I dispositivi medici nella pratica clinica e sperimentale”. In Italian. January 2013 At Dottorato in Scienze della Vita e della Salute, Politecnico di Torino, course: “Fabbricazione e certificazione dei dispositivi biomedici: dalla ricerca all’industria”. In Italian. September 2012 – October 2012 At Bioindustry Park Silvano Fumero: “Good Practices: quattro appuntamenti per le PMI sulle tecniche di Good Documentation e di Lean Documentation allo scopo di raggiungere i requisiti di conformità senza gravare eccessivamente sul sistema aziendale.” In Italian. Current projects as Free Lance Consultant- PGG Scientific CEO Training at DNV Italy as a Medical Device Directive Technical Expert and ISO 9001 and 134985 Lead Auditor. Status: expected completion first quarter 2014 Training at Eurofins TECH as a Medical Device Directive Technical Expert and ISO 9001 and 134985 Lead Auditor. Status: expected completion first quarter 2014 Implementation of a fully compliant integrated GMP and ISO 13485 QMS for VitalMed Inc. The company is a provider of OEM components for blood and IV sets. Located in Boston, MA (USA) and Reynosa, Tamps (Mexico). Certification of such system according to ISO 13485 standard. Reference NB: TUV and DNV. Establishment registration at FDA as Contract Manufacturer. Clinical Post Market follow up for a class IIa medical device, patented extracorporeal blood circuit, for Haemotronic spa. The company is a manufacturer of medical devices for haemodialysis, peritoneal dialysis, infusion and transfusion and a manufacturer of OEM components. For the same device, 510(K) submission foreseen within December, 2014. CURRICULUM VITAE of Alice Ravizza External reviewer for the development of the next generation of a class IIa medical device, patented extracorporeal blood circuit, for Haemotronic spa. CE marking of a second generation class III medical device: bone graft with animal origin substance for dental applications for Nobil Bio Ricerche s.r.l. The company is a provider of surface treatments for dental implants, a supplier of laboratory analysis for surface characterization and the manufacturer of this innovative implantable medical device. Full responsibility of Product and Process Validation planning, Risk management, Clinical evaluation, auditing management. Reference NB: DNV. Status: Design in progress Main projects developed as Free Lance Consultant- PGG Scientific CEO CE marking of a class I stand alone SW for Brainer s.r.l. Full responsibility of SW Validation planning, Risk management, Clinical evaluation and publication policy. Status: device registered at Ministero della Sanità CE marking of a class III medical device: bone graft with animal origin substance for dental applications for Nobil Bio Ricerche s.r.l. Full responsibility of Product and Process Validation planning, Risk management, Clinical evaluation, auditing management. Reference NB: DNV. Status: Certification pending approval Implementation and maintenance of a fully compliant integrated GMP and ISO 13485 QMS for Nobil Bio Ricerche s.r.l. Certification of such system according to ISO 13485 standard. Reference NB: Certiquality Clinical investigation (literature based) of a Automated External Defibrillator for CE Technical File and SFDA (China Food and Drug Administration) compliance for Progetti s.r.l. The company designs, develops and manufactures multiple Electro-Medical devices in class IIa and IIb. Reference NB: Istituto Masini Implementation and maintenance of a fully compliant integrated GMP and ISO 13485 QMS for Biotechware s.r.l. The company is a start-up at I3P Politecnico di Torino and a manufacturer of an innovative ECG monitor. Certification of such system according to ISO 13485 standard completed. Reference NB: Italcert CE marking of a custom made, wearable orthopedic device (orthesis) for hand function replacement for Functionable srl a start-up company at I3P Politecnico di Torino. Full responsibility of Product and Process Validation planning, Risk management. Status: device registered at Ministero della Salute Course “La progettazione dei dispositivi medici” for QualitySystems at a customer site. 16 July 2013 Main Projects developed at Haemotronic S.p.A: Engineering Patents- Patents pending • “KIT FOR THE EXTRACORPOREAL TREATMENT OF A BIOLOGICAL FLUID OF A PATIENT, AND UNIT PROVIDED WITH SAID KIT” EP2160213 (A2) marketed as device Chiaraset CURRICULUM VITAE of Alice Ravizza • • • “CHECK VALVE FOR A MEDICAL DEVICE “WO2009031018 (A2) ” CATHETER FLUSH AND FILL UNIT” WO2009147510 (A1) marketed as device Haemocatch “SACCA A PIU' COMPARTIMENTI PER SOSTANZE MEDICALI IN MATERIALE MULTISTRATO”, ITTO20050083 (A1) Validations and Design Transfers IQ-OQ-PQ and statistical analysis for process capability on manufacturing equipment for injection molding, extrusion, thermal welding, ultra-sound welding, radio-frequency welding, automatic assembly and manual assembly. Design, validation and certification according to Machine Directive of automatic assembly machines. Design and installation of manufacturing equipment in new sites, process validation and personnel training. Sites in Medolla (Italy) and Reynosa (Mexico) and for a customer in Wuxi (China). Design, validation and classification of ISO class 8 clean-rooms. Sites in Medolla (Italy) and Reynosa (Mexico). Main customers: Nutricia - Wuxi, ACS, Mergon, Baxter, Fresenius Medical Care – North America Main Projects developed at Haemotronic S.p.A: Quality Assurance and Regulatory CE Marking according to Annex II MDD for medical devices in classes III and IIa (extracorporeal blood circuits with and without heparin coating for dialysis applications, including patented devices see above; enteral and parenteral nutrition sets; IV sets) Quality System compliance to applicable European and International norms and laws, i.e. GMP, ISO 13485, Directive 93/42/CEE and following modifications and revisions, ISO 14971, series ISO 10993, series ISO 14644, series ISO 14155 and Meddev, process and product technical norms. Implementation of a fully compliant integrated GMP and ISO 13485 QMS in the manufacturing site of Reynosa, Mexico. (subcontractor of OEM components and subassemblies). Certification of such system according to ISO 13485 standard. Main customers: Baxter, Edwards, Teva, Baxa, Fresenius Medical Care – North America Education and Languages Biomedical Engineering Degree at Politecnico di Milano. Mother tongue: Italian English: bilingual proficiency. CPE certificate. Spanish: conversational proficiency. German and Chinese: elementary – beginner proficiency Autorizzo il trattamento dei dati personali ai sensi del D. lgs. 196/03
© Copyright 2024 Paperzz
