QMS Quality Management System
Product ID : WIRA-0002
Level : Beginner
Duration : 60 Minutes
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)
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.
- Overview and Definitions
- The reasons why connecting something and what for
- The two pillar of the company’s knowledge or actual asset
- Common mistakes and today's problems
- Best practices or the ideal setup
Course Level - This webinar is about the basics of a QMS. Without knowing what the basis is and which parts are important, a QMS cannot be created and maintained properly.
Who Should Attend
- 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
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.