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today were going to talk about process validation but not just any process validating were going to talk about process validation for a process that you cant find a standard for what do you do then so in the medical device industry in a 510 case mission you have to provide um a process validation for sterilization sometimes you have to provide it for other things but normally for the manufacturing process thats only covered internally and then inspected during an fda inspection when youre submitting a technical file for ce marking they want to see that process validation documentation they want to see a process flow for the entire manufacturing process they want to have on that process flow references to your detailed work instructions to your procedures they want a copy of that validation and it has to be thorough so you need a complete validation protocol you need a validation report you need the raw data and they want it summarized for them so they dont have to read all that s
