Medical Device Process Validation - Overview: Part 2


The post has been split it into two parts (Part 1). In Part 2 we will continue with an overview of medical device process validation essentials, including:

  • Continue the OQ discussion in Part 1, with challenge strategies

  • Cover risk and statistical confidence/reliability

  • PQ

  • Post-PQ activities: process monitoring and revalidation

As in Part 1, I've decided to write this post from the beginning as a slide presentation. In doing so, my hope is that the text and visuals provide a more appealing and memorable treatment of this important topic.


To Download an enhanced presentation PDF that includes Part 1 and Part 2 of the post, click Here.



End of Part 2.


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