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Medical Device Process Validation - Statistical Considerations
This Process Validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
The FDA’s Quality system regulation requires device manufacturers to validate processes when they don’t fully verify the resulting output. Based on Warning Letters, the FDA expects manufacturers to validate processes when the output check uses sampling instead of 100% inspection.
The presentation looks at these aspects of process validation using the unifying approach of a statistical model. Rather than a fundamental examination of how to perform process validation, this seminar covers the tools necessary to use the statistical model.
Why Should You 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 is the essence of the statistical approach.
This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions.
- Can you give the statistical rational for you verification sampling plans?
- Can you state the desired and actual process capability you need to achieve?
- Can you list the worst-case input parameter combination for your process?
- Do you know how to determine challenge points for your process?
- Have you set action limits for your process inputs?
Areas Covered in the Seminar:
- QMS Requirements for Process Validation.
- FDA’s QSR (21 CFR §820.75)
- ISO 13485:2003
- The Statistical Process Model.
- Relating input to output
- The Process Output.
- Sampling Inspection
- Process Capability
- The Process Input Parameters.
- Design of Experiments
- The Challenge Points
- Risk Management.
- Production Information
- Validated Processes as High Risk
Who Will Benefit:This seminar is for people involved in the validation of production processes. Validation requirements start in the design output (setting the requirements), continues to design transfer (where the requirements are set as process parameters), and finally to process validation to ensure the resulting output achieves the requirements
- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
- Design Engineers
- Process Owners
Daniel O'Leary, 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.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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Daniel O Leary
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