How to perform your Process Validation for medical devices? (IQ OQ PQ)

[@ammusumesh]

Excellent summary in a nutshell...this summary looks a lot like we do in our company...this podcast serves as a validation of our thinking on this topic

[@UmeshVeer-ip1fs]

Thank you for the detailed information. but I have one question. How to perform validation of process for customized medical device?

[@adilahmed-xr1fh]

Urs-FAT-SAT-DQ-IQ-OQ ,Sop and finally PQ..

[@arunthomas7863]

Great session and very useful

[@EasyMedicalDevice]

Thanks for your support

[@DogWithHangover]

Superb discussion. Thank you!

[@mdshahinazad9283]

Very good information sir... Thank you so much dear sir❤️

[@dineshbhardwaj195]

Thanks for detailed information and explanation.

[@EasyMedicalDevice]

You’re welcome

[@theresajonker5888]

Excellent topic thank you for this comprehensive overview of an iceberg topic. Are you planning a separate DQ discussion? Including a legal challenge for marketing surveillance before and after the going to market or phased human trials?

[@EasyMedicalDevice]

Hi Theresa, Nothing planned for now but I can look at it for another episode

[@arunakeerthi8148]

Thanks for info and the validation toolkit is so useful

[@legtears1]

Is the link for downloading the templates still working? I tried to download them with no success

[@msantos4313]

Excellent information, but I thought that the rule of 3 has been removed and is no longer recommended since companies were defaulting to it instead of providing statistical significance, what do you think? Is that accurate? Please correct me if I am wrong.

[@EasyMedicalDevice]

Hi, not at all. There is no specific methods that are described to execute this. But this rule of 3 is providing some statistical measures to confirm the validation is correct. This was also recommended on the GHTF guidance. So this proves it is really considered by all companies.

[@NM-fj7jl]

Can you kindly provide the steps of IQ,OQ PQ for steam sterilizer?

[@Dycdom]

Normally you are following the protocol… or if there none then you might have to create… and in that case FAT/SAT would be very helpful.

[@rohithteja4202]

What’s the difference between Process Validation and Equipment Validation?? How do you define that ??

[@EasyMedicalDevice]

I would say this is the same but maybe that process validation can be for a succession of equipment. Like validation of 3 successive equipment. And equipment validation is for 1 equipment.

[@thomasandrew6432]

Great useful sharing!

[@rubazaki]

Very knowledgeable.

[@EasyMedicalDevice]

Thanks ruba, really appreciated

[@babafunsoadenuga2455]

What is the difference between process validation and machine qualifications?

[@Dycdom]

Machine qualification is going under process validation which is covered much wider range of different tasks

[@premkumar-mc8ez]

Nice 🙂

[@salmanbaghwaan7076]

Do we need PQ on post sterile products or only pre sterilized? Please someone answer this. Thanks

[@hatimnoli]

Both.

[@Dycdom]

You are PQ every single individual equipment

[@moadbouzida6693]

GOOG CONTENT , MERCI

[@prashantpathak3175]

I feel the organiser is interrupting too frequently with his questions and that distracted me a lot.

[@YePapoteGlobal]

🙏

[@mohammedasif7667]

Monir let your guest speak more then you or else we lose the consistency or what topic is about

[@EasyMedicalDevice]

Thanks for your feedback. Sometime I get also too excited about the topics I am talking about so sorry for that.

[@mohammedasif7667]

@@EasyMedicalDevice no need to be sorry I learns a lot from you 😁 you are a GURU

[@mrinalineerangole7672]

The person taking interviwe is unnecessarily talking and making interview bad