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…
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…
Architectural design of the entire facility with respect to GACP/GMP flows: Complete series of layouts, plans and studies. Development of all areas with facilities and equipment incl. equipment arrangement, position…