Statistical Concepts of Process Validation

Duration: 90 Minutes
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.
process validation
Instructor: Daniel O'Leary
Product ID: 501979
Objectives of the Presentation
  • 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
Why should you Attend
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 verify 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.

Who will Benefit
This webinar is for people involved in the validation of production processes. Process validation starts with design output (setting the requirements), continues through design transfer (where the requirements become process parameters), and achieves a validated process for production. People in the following roles can especially benefit from the presentation:
  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
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Instructor Profile:
Dan is the 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 is certified by APICS in Resource Management.
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