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)
June 18 2019
12 : 30 PM EST
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 s..
August 05 2019
01 : 00 PM EST
FDA, EMEA, and ISO9001 want you to have a CAPA system in place. This is the first of three in themselves closed Session about CAPA system (the basics)Change is unavoidable; it attacks your processes and products at all times. The creation of a CAPA system should not be an empty exercise in regulatory compliance but an integral part of the company’s risk mitigation; against all forms of negative influences o..