CAPA - Corrective and Preventive Actions
"Well structured course, plenty of time to cover topics and ask questions. Good mix between active and passive learning." Course participant, Autumn 2010
Who should attend?
Quality Assurance and Regulatory Affairs professionals and those responsible for CAPA implementation, as well as those who manage and monitor the CAPA process.
More than 50% of FDA’s 483 observations and Warning Letters are CAPA related.
The suboptimal use of CAPA, however, not only risks enforcement action, but misses an opportunity for companies to improve internal processes and products and better achieve business objectives.
The course will present and assist in the understanding of the requirements and expectations of CAPA to meet the US FDA and European Medical Device Standards.
The following subjects will be covered:
- Introduction and overview of regulations
- Developing a feedback system
- Handling of nonconforming products and decisions
- Failure analysis
- Corrective and preventive action procedures
- Improvements and follow up
- Data, documentation and trending
- FDA expectations and case studies
The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.