Overview:
This presentation will outline five targeted improvements to enhance the quality and effectiveness of Nonconformance and CAPA records. In addition to strengthening record content, it will offer practical guidance to support sound decision-making throughout the Nonconformance and CAPA process. Each improvement will be accompanied by real-world examples and actionable steps to support successful implementation.
By adopting these strategies, organizations can expect to achieve:
- Higher-quality Nonconformance and CAPA documentation
- A reduction in the volume of investigations
- Lower risk of findings during regulatory inspections
Why you should Attend:
Nonconformance and CAPA records are routinely reviewed during regulatory inspections. To minimize the risk of observations, it's essential that your nonconformance and CAPA processes produce audit-ready documentation. A robust CAPA system not only helps identify and prioritize the right records, but also ensures that the content is thorough, well-justified, and inspection-ready. This presentation will provide practical tools and strategies to enhance the quality and effectiveness of your nonconformance and CAPA records.
Areas Covered in the Session:
- Nonconformance/CAPA Basics
- Description of each improvement
- Examples of each improvement
- Implementation basics of each improvement
- Description of how proposed improvements will address record quality, quantity, and regulatory risks
Who Will Benefit: