Statistical Concepts of Process Validation

Overview:

Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.

When you cannot (or do not) fully verified process results by subsequent inspection and test this leads to sampling plans. We discuss the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, then your process achieves a certain process capability. We discuss the concepts of process capability, especially the use of Cp and Cpk. Operational Qualification (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.

Lastly, Risk Management (ISO 14971:2007) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

Why you should Attend: 

If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This presentation provides the background you need on the statistical approach to process validation.

Areas Covered in the Session:

• Understand the QSR requirements for process validation
• Explain the FDA's approach as documented in Warning Letters
• Understand the ISO 13485:2016 requirements for process validation
• State the statistical model that links process input and process output
• Link sampling verification to the process model
• Understand the role of process capability and describe the desired values of the indices
• Understand the role of designed experiments in determining the input parameter space
• Describe the role of challenge points in Operational Qualification
• Recognize the role of process validation in Risk Management

Who Will Benefit:

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