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)
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Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees. The reason to have a QMS is not to satisfy the regulators, but for any employee to find the reason for doing the work they should do and how it is connected to the rest of the company.Any of you who wants to do a good job needs to know the reasons, rules, and ..