Robust CAPA Process for Medical Devices
Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.
More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications
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, it will be presented as 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.
- Corrections, Corrective Actions and Preventive Actions
- Courses for CAPA
- Root-cause Analysis
- CAPA Management
Course Level - Basic - Intermediate
Who Should Attend
- Quality Engineers and Quality Managers
Why Should You Attend
- The purpose of this webinar is to present what are the requirements for a robust CAPA process
- The webinar shall provide tools and examples of how to analyze and identify a root-cause and provide a mechanism to mitigate them
- Also, the webinar shall provide insights into how to manage CAPA in daily manner