Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), a 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)
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 on product or service development, marketing, and logistics, for the future.
What can you do to provide the same quality in the future?
A concept with processes for flexibility to manage unknown changes is called a CAPA system (corrective actions and preventive actions).
- Overview and Definitions
- The history of CAPA – you need to know the background to be able to use it properly
- Why should you use something like CA and PA
- Lessons learned (medical equipment)
- Common mistakes and today's problems
- Best practices – the ideal process
- When and how should you implement a CAPA process
Course Level - Learn about CAPA-System’s background, which is essential for keeping up a high level of quality within any company. To understand something fully, you need to know where it comes from; it’s history
Who Should Attend
- Quality Assurance Professionals
- Safety Professionals
- Clinical trial and medical device Operations Professionals
- Oversight and Middle management
- Product (or service) controlling and testing Professionals
Why Should Attend
The cost of poor products or services can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers are all results from poor quality management.
Following various incidents, the control mechanisms for medical devices - from heart valves to sticking plasters to artificial hips – are being tightened.
Most companies are asked to implement a product monitoring system that records product-specific complaints not just companies in pharmaceutical or medical devices areas (including software providers for them) but any company with the aim, to produce high quality and very useful products.
Corrective Actions need to be taken as soon as a complaint is lodged or nonconformities are found. Preventive Actions are the outcome of a continuous process against any negative side effects of changes or influences, and for the safe and good performance of designing, developing, producing, the logistics and marketing of products and/ or services.