SKILLS

DEGREE OF KNOWLEDGE / EXPERIENCE

EDUCATION / PROFESSIONAL QUALIFICATIONS

Degree in Business Administration - University of Pavia, 07/1997EOQ Quality Sistem

Diploma Manager (EOQ European Organisation for Quality), 3 / 1998

Diploma of Assessors for the "Business Excellence" according to the EFQM (European Foundation for Quality Management), 5 / 1999

Diploma of Third Party Auditor for Environmental Management Systems (ISO 14001 - EMAS) Ltd SGS ICS (International Certification Services), 11/2000

Certificate of participation in the course QS-9000 approved by Chrysler, Ford, General Motors, Bureau Veritas Quality International Ltd 5 / 2001

Diploma of Third Party Auditor for Quality Systems ISO 9001 IRCA undetectable, Bureau Veritas Quality International Ltd, 7 / 2001

EXPERIENCE

From April 2002, founder and CEO of consulting firm "Exem Consulting SA"

On behalf of "Exem Consulting SA" provides consulting in ISO 9000 and strategic organization and in different sectors, including health care and activities of the Quality Manager of Outsourcing 'Regional Hospital of Bellinzona and Valli

Since 2004 I work as a project manager or project supervisor for the accreditation of a bone marrow transplant unit in the standard Jacie.

Since 2004 I work as a project manager to oversee and manage projects for the certification of facilities according to ISO 9001:2008 transfusion

November 2012, President of Exem Turkey

June 2013, President of Exem Italy

SPECIAL SKILLS

Expertise

Expertise in strategic areas of Quality and Regulatory Affairs in:


• JACIE quality standards in Stem Cell Transplant Programme

• EFI quality standard in HLA laboratory

• FACT-NETCORD quality standards in Cord Blood Bank
• 
GMP standards for quality in Tissue Banks

• Quality standards in Fertility centers 

• Expert in biobanking and clean rooms market
• 
Expert in European legislation concerning the Stem Cell, Tissues and Fertility

Expert in management of Observational Studies

TEACHING

Teaching the course "10007 and ISO 9000-3," AED Auselda Group, May 1998

Teaching the course "Quality Facilitator" Airlines Training Center, June 1999

Teaching the course "Internal Quality Auditor" Locarno Regional Hospital Charity, January 2000

Teaching the course "Project Management", SAIS SA, January 2001

Teaching the course "Internal Quality Auditor" Farina Presse Srl, January 2001

Lecturer, "The new ISO 9001:2000 revision", Society contractor Ticino, March 2001

Teaching "Quality and ISO 9001:2000" at the school of nursing in Stabio

Teaching "The standard JACIE transplants in the program" Hospital of Cuneo, 2008

Teaching "The standard in the program of bone marrow JACIE Hospital” San Camillo Forlanini

Teaching “The Breast unit quality accreditation”, Sofia (Bulgary), 2009

Teaching “Standards and accreditation pathways in transplant center" during the conference "The transplantation of bone marrow and hematopoietic stem cells," Acaya (Lecce), April 2010

Teaching “Risk assessment and patient safety”, Sassari, Italy, June 2010

Teaching “Quality Transplant accreditation”, GITMO (Italian Group of transplant) National Congress, December 2011

Lecture “Evaluation of the risk-benefit of the fotoferesi process” during the Consensus Conference GITMO-SIDEM, April 2012

Professor in the Aquila University Master Degree for quality assurance in the tissue banks, 2012 and 2013

PUBLICATIONS

Participation in the publication of Regional Agency in Veneto, with the article "The accreditation JACIE: excellence centers for hematopoietic stem cell transplants"

Participation as a co-author of the document "Structural requirements and organizational models as part of a service dedicated to the collection of apheresis of autologous stem cells"

Participation as a co-author of the document "Accreditation JACIE Stand-alone: pathways and results"