Effectiveness Measures in CAPA and Risk Management Plans: Applying LSS For Quality Metrics
Tuesday, February 12, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This webinar on quality metrics for lifescience companies will show how you can apply the Lean Six Sigma methodology in the context of the CAPA and risk management processes. It will use a case study approach to demonstrate how you can use the LSS approach to define useful and meaningful quality metrics.
Why Should You Attend:
Appropriate, reliable, measurable and accurate metrics are the guiding principles for successful CAPA activities. The Lean Six Sigma approach provides a systematic way to define useful and meaningful effectiveness metrics.
This webinar will focus on the application of the LSS methodology to the CAPA and Risk Management processes at Drug and Device manufacturing companies. It will provide specific industry case studies of how organizations have successfully used the methodology to define an appropriate problem statement following the SMART principles (Specific, Measurable, Attainable, Relevant &Time-Bound), define Critical-to-Quality (CTQ) measures that have failed to meet customer requirements, develop metrics that best gauge the performance of the CTQ, and measure current process performance/capability. All these elements will provide the required foundation to ensuring successful root cause investigation & effectiveness of solution.
Areas Covered in the Webinar:
- Overview of Lean Six Sigma (LSS) Methodology
- How LSS fits into the CAPA & Risk Management framework
- Definition of robust problem statements using SMART principles
- Definition of Critical-to-Quality (CTQ) – needed for development of metrics
- Examples of accurate, measurable, relevant metrics
- Measurement of process capability
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.