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)
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..
October 15 2019
12 : 30 PM EST
This webinar will show you that there is no sense in tackling the ‘keeping’ of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records.If you are part of the process of ‘Collecting’ (e.g.: from study nurse to x-ray specialist), ‘Using’ (e.g.: from sponsor to report programmer, or statistician), or ‘Keeping’ (e.g.: from c..