Medical Device Process Validation - Statistical Considerations (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Feb 08, 2012||End Date/Time: Feb 08, 2012|
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 â€“ 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?