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 should you 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
Speaker Profile
Alicia A. Rice RAC-Devices, has more than 30 years of industry experience including Medical Device operations management and extensive experience in the assessment, development, and deployment of new processes. She has a Bachelor of Industrial Engineering degree from Georgia Institute of Technology, which, along with her industry experience, uniquely qualifies her to evaluate and implement quality-compliant, lean, and sustainable processes. She is currently Chief Operations Officer of Advance BioReg, a healthcare regulatory and compliance consulting firm.
She has broad industry experience across multiple Fortune 500 firms, including Baxter Healthcare, Johnson & Johnson, and Abbott Laboratories. This experience includes projects related to CAPA process development, record remediation and training, software methodology development and assessment, process validation, packaging and labeling operations, and internal and external auditing - a diverse background that brings a holistic approach to every client project.
Instructor
Alicia Rice
