Willi Ramseier, the Owner and the Director of QVRAM GmbH. A Well renowned Expertise in Quality assurance, system Validation, Risk -Awareness and risk-Management
Willi Ramseier is a reputed trainer, mentor and a Quality compliance officer. He is an expert at Big Pharma company at Germany serving as Project and Process Guidance and Trainer being a Quality assurance and Compliance Officer.
Willi serves as a Process-Validation Expert at Synthes-dePuy-Johnston&Johnston Switzerland. Quality Consultant for a CRO in Cologne; providing hands-on help with process- documentation, requirements creation, planning, CSV (computerised system validation). CSV auditing He also involves himself completely in CAPA plan reviewing as a QA, and GxP Workshop Trainer for a CRO, Dresden
Willi aids the small companies on the new regulatory aspects. Mentoring the young quality-consultants, Start-ups companies. Early to his career as a consultant Willi has a good amount of management skills which certainly has helped him assisted him in all stages of his career so far.
Willi Ramseier’s areas of expertise: eClinical, eCRF, Data Management 21 PART 11, electronic records and signature Risk -awareness, -assessment, -management Risks and hazards at logistics of human samples and drugs CSV computerized system validation GxP, Quality Assurance, System/ Process Validation Creating and maintaining QMS quality management systems Data flow in clinical trials, Process management e.g.: DIA, cbi center for business intelligence, SMi Group, Arena-international, SAS Sweden, Roche -Global, -Basel, -Ireland.
Following various incidents, the control mechanisms for medical devices - from heart valves to sticking plasters