Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), the consultant for general quality issues (especially for start-ups). His assets : -Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche) -Vendor Audits and Quality Reviews -Concepts for the quality management system, CAPA system, Change management, ISO9001:2015 -Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans (create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology) Variety of work: -IT projects (from quality assurance and validation to access concept and security) -Lab projects (pathology, CPU, DNA, RNA) -Clinical trial teams quality assurance (Report validation, endpoint adjudication, Web sites) -CRO’s (clinical research organization)