2600 E. Bayshore Road Palo Alto, CA 94303
CA, California 94303

Course Description:
Many companies have adopted the Lean Six Sigma Methodology in order to improve the efficiency and quality of manufacturing and business process while maintaining the low cost. With its statistical analysis and techniques, Lean Six Sigma Methodology is helping the companies to ease the risk management and improving the performance by eliminating the defects. This webinar will provide a detailed description on how the life Science product manufacturing companies can apply Lean Six Sigma to define effective and meaningful quality metrics.
Course Objective:
All life Science companies could improve their FDA CAPA investigations and risk management by implementing new and effective methodologies. The Lean Six Sigma approach provides a systematic way to define an effective quality metrics for CAPA and risk management. LSS methodology enables the companies to identify and meet customer needs by maintaining an active problem solving. This webinar will focus on the application of LSS to the CAPA and risk management process at life science product manufacturing companies. This course helps the attendees to learn how to identify and assess non conformances or problems and how to implement an effective preventive action by using the LSS methodology. It will provide specific industry case studies of how organizations have successfully used the methodology to define an appropriate problem statement following the SMART (Specific, Measurable, Attainable, Relevant &Time-Bound) principles. This will also define the critical to quality (CTQ) measures that have failed to meet the customer requirements.
The course will cover the following areas:
• Overview of Lean Six Sigma (LSS) Methodology
• How LSS fits into the CAPA and 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
Who will benefit:
This webinar will be beneficial for the following regulatory personnel:
• Investigators of deviations, non-conformance, product complaints and supplier issues
• CAPA Specialists
• Process and Design Engineers
• Manufacturing
• Production and Operations
• Internal audits
• Regulatory Affairs and Product Safety Specialists
• Design and development teams performing Risk Assessments and FMEAs

For Registration:

Added by complianceonlinecom on November 30, 2012