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.
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 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
Speaker Profile
Yuval Shapiro is the founder of QWV - Quality with Value, QA or 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 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.
Instructor
Yuval Shapiro
