Overview 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 standards in this company and on that job. A QMS is therefore essential, and this webinar can help you to understand the basics of a QMS and how important your part is in saving the company resources and be compliant. Why should you Attend The cost of not finding something at an inspection, or of missing knowledge can be staggering. Having to do things a second time, because of lost know-how, costs resources. Any auditor or inspector can ask you to show, why you do what you do in comparison to the framework of the company. Most companies working in the health area have defined the safety of patients, their clients, as one of their main goals within their overall policy. This is The base-stone; everything within this company is build-on. Areas Covered in the Session Overview and Definitions The reasons why connecting something and what for The two pillar of the companys knowledge or actual asset Common mistakes and todays problems Best practices or the ideal setup Questions Who Will Benefit Quality Assurance Professionals Validation Professionals Standards and SOP Professionals Data Management Professionals Electronic Systems Developers The inspection readiness team Clinical and medical device Operations Professionals Project leaders Speaker Profile 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. Event link: https://www.traininng.com/webinar/-200829live?channel=internationalfair-May_2019_SEO Contact Info Traininng.com LLC Email: traininngdotcom@gmail.com Phone: US: (510) 962-8903 Phone: Zurich: +41 - 43 434 80 33 Website : https://www.traininng.com

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