Palladio Consulting srl
I have over of 35 years’ experience in pharmaceutical microbiology and sterility assurance for sterile and non-sterile productions. During my distinguished career I led a series of technology-driven pharmaceutical processes improvements using scientific methods including new technologies leading a series of initiatives such as Process Analytical Technologies (PAT) and Rapid/Alternative Microbial Methods (RMM) that improved quality and process understanding while yielding significant cost savings, obtaining GMP compliance and regulatory approvals (FDA and EMA).
In 2003, my microbiological laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. In 2005, I obtained the first approval in Italy for parametric release of terminally sterilized products. In 2008, I obtained the first FDA approval for microbiological real-time release for a non-sterile clean liquid product. I was a key member of the GSK Aseptic QA & Biological Laboratories Group within the Quality Assurance Directorate.
Today I’m the Technical & Scientific Director for Palladio Consulting.