Medical Device Process Validation - Overview: Part 1


What is Process Validation?


This is a frequently encountered question in the medical device industry and one that I hope to provide a brief overview of.


The post has been split it into two Parts. In Part 1, we will:

  • Provide some definitions

  • Distinguish between verification and process validation

  • Cover Installation Qualification (IQ)

  • Briefly mention process characterization (which is so important it will get its own separate post later)

  • Begin our discussion of Operational Qualification (OQ)

I've decided to write this post from the beginning as a slide presentation, in the hope that the text and visuals provide a more appealing and memorable treatment of the topic. It is my sincere hope that in so doing, you may get the most value from it.


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












End of Part 1.




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