Statistical Concepts of Process Validation

Dan O'Leary

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This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.

Why Should You Attend:

Process validation is an important element in medical device manufacturing. 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 webinar 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. The presentation discusses 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 may carry the greatest risk.

Areas Covered in the Webinar:

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

Who Will Benefit:

This webinar is for people involved in the validation of production processes. Personnel 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
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Dan O'Leary, President at Ombu Enterprises, LLC

Daniel O'Leary 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 Master’s Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma black belt; he holds an APICS certification in resource management.


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