Vittorio Mascherpa Fedegari

Born 1946 in Milan (Italy), Vittorio Mascherpa he graduated 1970 with full marks and honours as 'Dottore in Ingegneria Chimica' (Chemical Engineering) at the 'Politecnico di Milano' and is a registered professional 'Ingegnere' since 1971.

1971-72 he served in the Italian National Service as an Officer of the S.Te.A. (Technical Department of Artillery).

Between 1972 and 1980 he worked for chemical industry (process engineering and project management), then he was engaged by pharmaceutical companies (Glaxo S.p.A. and Istituto Biochimico Italiano S.p.A.) for engineering and maintenance. He has been intensively involved in successful validation projects.

1988 he joined Fedegari Autoclavi S.p.A. (R&D Laboratory) and was initially in charge of the functional tests of the new electronic controllers. Later he became responsible for the process specification of the controller software and progressively imported into the Company the development activities of application process software.

He has been R&D Manager since April 1992 until his retirement in 2003. Since then, he co-operates with Fedegari Autoclavi S.p.A. as registered Engineering Consultant.

1992-94 he participated from the very beginning in the developing of the First and Second Draft of the GAMP Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture; in the following years his care was to ensure the training of Fedegari R&D Department Personnel in the application of the subsequent versions of GAMP Guide.

Since 1999 he has been an active member of the PDA's Task Force Europe for the revision of TM no. 1, 'Validation of Moist Heat sterilization in Autoclaves'.

He is also member of Sub-Committee 12 ('Sterilizers') of UNI (Italian Standars Body) and of CEN TC102/WG2/3 ('Testing/Requirements for Sterilizers'), engaged at present in the revision and “maintenance” of EN 285 Standard.

On behalf of Fedegari Autoclavi S p A., since 1988 he has lectured more times per years on all topics of industrial sterilization, both for fidelized or new Customers and for national or foreign Inspection Bodies.