Dalmaso Gilberto

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK) where he started in 1984 with Glaxo Verona (Italy). During his distinguished career at GSK he led a series of technology-driven process improvements using scientific methods, while achieving GMP compliance and regulatory approvals.

Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings. In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. In 2005, he obtained the first approval in Italy for parametric release of terminally sterilized products. In 2008, he obtained the first FDA approval for microbiological real-time release for a non-sterile clean liquid product. He finished his GSK career as a key member of the Aseptic QA & Biological Laboratories Group within the Quality Assurance Directorate.

Today Gilberto is the Technical & Scientific Director for Palladio Consulting srl. In this role he collaborates and consults with pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes. He’s also a qualified training for the most important regulatory agencies. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, regulations interpretation and method.