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nonconforming materials report

Conducting Effective and Compliant Validations – An Example

You work for a company which produces a sterile, medical device. A new Tray Sealer was recently purchased, and requires validation. You were asked to write the Validation Protocol. What does the Validation Protocol need to include?

This White Paper is a follow-up to PathWise 2016 White Paper “Conducting Effective and Compliant Validations”. The focus is upon applying the elements that were introduced. An example will be provided to demonstrate appropriate Validation Protocol content.


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