- TypeWebinar
- Location Online Event
- Date 22-09-2021
Business Development
Medical/Healthcare/Hospital
Live Webinar: Corrective and Preventive Action (CAPA) When: Wednesday September 22, 2021 - 01:00 PM Duration: 60 Minutes.
Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2016, ISO 9001:2015 and FDA under 21CFR 820 & is typically found in FDA Warning Letters. This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements. It will include discussions on root cause analysis, quality system trending, corrective action effectiveness, and how CAPA is critical to be linked to other parts of the quality system including customer complaints, manufacturing nonconformities, customer feedback, supplier performance, etc. Lastly, this course will include the consequences of poor adherence to these pro
Areas Covered in the Session:
Regulatory Requirements
Correction vs. Correction Action
CAPA & Risk Management
Determining Root Cause
Tools for Root Cause Analysis
Corrective Action Effectiveness
Quality System Trending
Linking CAPA to other parts of the QMS (Quality Management System)