Healthcare Training 2019 - CAPA System

Overview
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).
Why should you 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.
Areas Covered in the Session
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
Questions
Who Will Benefit
Quality Assurance Professionals
Safety Professionals
Clinical trial and medical device Operations Professionals
Oversight and Middle management
Product (or service) controlling and testing Professionals
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