How to Develop a strong CAPA System by Understanding its Unique Challenges 2016 is a webinar that covers topics such as:
- 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
How to Develop a strong CAPA System by Understanding its Unique Challenges 2016 is intended for 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
