Medical Device Process Validation - Statistical Considerations

Dec. 16, 2011 - PRLog -- 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?

For  Registration:
http://www.complianceonline.com/ecommerce/control/trainin...

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