Corrective and Preventive Action (CAPA) violations were noted in 91% of all quality-related warning letters issued to device manufacturers by FDA in 2010. This extremely high violation rate underscores the importance for firms to implement and maintain a comprehensive and compliant CAPA process – a critical component of any well-functioning quality management system.
A large number of open CAPA events can create backlogs and bottlenecks throughout a company, making even the most efficient of CAPA processes seem difficult to sustain. Developing and using effective risk assessment tools, however, can alleviate those issues and be a key to ensuring that CAPAs are adequately addressed – in the right order, at the right time.
"The FDA reviews all CAPA information – from any source –-- regardless if it is from internal audits or not," - Kim Trautman, FDA’s Medical Device Quality Systems Expert, recently told "The Silver Sheet."
To de-clutter your CAPA approach, attend this 90-minute webinar – presented by Jackie Torfin, Vice President of Quality at Heraeus Medical Components – and see how you can build a simple, yet powerful tool that can help you align resources and expectations throughout your organization to keep your CAPA system on the right track.
Attendees will:
- Realize the value of using a risk assessment tool in the management of a CAPA program
- Build a risk assessment tool that will address the severity of problems and calculate its probability of occurrence
- Incorporate a semi-quantitative risk assessment tool into their own CAPA systems
- Be able to ask questions during a live Q&A session
With medical device firms under significant FDA pressure to comply with regulatory requirements and improve overall quality, this webinar provides critical information on CAPA that will lead to quality management success. Register today!