How to Develop a strong CAPA System by Understanding its Unique Challenges 2016

Topics

• Current Guidance Documents
• CAPA requirements per Quality System Regulations 21 CFR 820, 210/211 and ISO 13485
• Importance of preventive action system to reduce number of CAPAs in the long run
• What works for CAPAs dealing with different manufacturing areas and different product histories
• Essential component of a well-documented CAPA system
• Risk-Based Assessment
• Prevention of failure repeatation
• Root Cause of product/system failures, nonconformance, product complaints, and audit findings
• Testing for long term effectiveness of the changes
• Quality Tools to be used to close the CAPA
• CAPA board roles and responsibilities
• Practical examples
• Preventing FDA 483s, warning letters and recalls

Who should Attend

Attendees involved or interested in:

• Process Engineering Departments
• Manufacturing Departments
• Design Assurance Departments
• Research & Development Departments
• Quality Control Departments
• Quality Assurance Departments
• Document Control Departments
• Production Operators and Supervisors
• Regulatory Departments