This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process
How do you prevent becoming another FDA statistic? 88% of all Warning Letters issued in 2005 to medical device companies for Quality System/GMP deficiencies included a CAPA citation. Nearly 30% of all 483s issued that year contained a CAPA related observation. CAPA is the key to strong Quality Management System. This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process. This program is designed for the medical device, IVD, and combination product industries.
How do you prevent becoming another FDA statistic? 88% of all Warning Letters issued in 2005 to medical device companies for Quality System/GMP deficiencies included a CAPA citation. Nearly 30% of all 483s issued that year contained a CAPA related observation. CAPA is the key to strong Quality Management System. This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process. This program is designed for the medical device, IVD, and combination product industries.
Areas Covered in the seminar:
- FDA Inspection trends related to CAPA
- CAPA data sources
- Elements of a successful CAPA system
- Integrating risk management
- Root cause investigations
- Common CAPA mistakes
Who Will Benefit:
- Quality Assurance/Quality Systems
- Compliance/Regulatory Affairs
- Operations
- CAPA Management
- Engineering
- Document Management
- Auditing
Course Provider
Susan C Reilly,
