Process Validation for Medical Devices
The benefit of a consistent process validation for medical devices is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes.
This Video shows the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
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