Healthcare 2021 - Bulletproof CAPA Process: How To Do It Right?

Overview:
Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice.
The difference between Correction, Corrective Action, and Preventive Action will be discussed. Mr. Shapiro shall present common sources for CAPA, tools for root-cause-analysis, e.g. - 5Why, Cause, and Effect Diagram, Pareto Charts, etc. Also, will be presented an effective mechanism for CAPA management.
CAPA - Corrective and Preventive Action is the cornerstone of quality management systems in the medical devices industry. Quality Managers are struggling on a day-to-day basis on how to make CAPA a common practice of the organization.