cGMP compliance, regulatory issues, validation strategy and quality systems, acc. to EU cGMP / FDA 21 CFR, practices, HACCP/GFSI, GACP. Gap Analyses and Risk Assessments for systems, processes & products. Pre-audit…
Patent and Bibliography search combined with Process Development analysis towards definition of Drug Registration strategy. Review of the most updated literature (scientific publications and patents) and industrial insights regarding R&D,…
Factory Acceptance Tests (FAT) participation at manufacturers sites (worldwide) for critical procurements (R&D, Manufacturing and Quality Control). Approvals release for FAT documents. Site Acceptance Tests (SAT) organization & Training for…