Bulletproof CAPA Process: How to do it Right?
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.
Why you should 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 a daily manner.
Areas Covered in the Session:
- Corrections, Corrective Actions, and Preventive Actions
- Sources for CAPA
- Root-cause Analysis
- CAPA Management
Who Will Benefit:
- Quality Engineers
- Quality Managers
More than 20 years of experience in QA; including MD and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.