Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.

When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.

Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.

Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

This audio conference covers:

• The statistical approach that will help you validate your processes
• Understanding the statistical rationale for your verification sampling plans
• How to state the desired and actual process capability for a process
• How to determine the worst-case input parameter combinations
• Determining challenge points for your process
• Setting action limits for your process inputs

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Who should attend?

• Quality Managers
• Quality Engineers
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners