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

► Webpage: podcast.easymedicaldevice.com...
Process Validation is a science but it needs also some education. In this episode of the Medical Device made Easy Podcast, we will help you understand what is Process Validation. If you are a Medical Device Manufacturer or if you are an engineer that wants to understand Process Validation, then this episode is for you.
We will talk with Adnan Ashfaq from Pharmi Med Ltd. He will share with us his experience and provide some valuable tips to be successful within this process.
Some of the topics we'll cover are:
- FAT SAT IQ OQ PQ
- Prospective and retrospective validation
- Soft skills to be a good Validation Engineer
- What is the most common issue in a validation process?
- Validation templates.
Don't hesitate to contact Adnan Ashfaq to help you with your Validation Process.
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► Who is Adnan Ashfaq?
Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market, and stay in the market.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
■ Adnan Ashfaq Linkedin: / adnan-ashfaq-44478121
■ Pharmi Med Ltd: www.pharmi-med.com/
■ Validation Toolkit to download: mailchi.mp/easymedicaldevice/...
■ Blog post Process Validation or Verification: easymedicaldevice.com/medical...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance

[@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

[@thomasandrew6432]

Great useful sharing!

[@arunakeerthi8148]

Thanks for info and the validation toolkit is so useful

[@mdshahinazad9283]

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

[@adilahmed-xr1fh]

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

[@UmeshVeer-ip1fs]

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

[@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

[@DogWithHangover]

Superb discussion. Thank you!

[@moadbouzida6693]

GOOG CONTENT , MERCI

[@dineshbhardwaj195]

Thanks for detailed information and explanation.

[@EasyMedicalDevice]

You’re welcome

[@legtears1]

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

[@rubazaki]

Very knowledgeable.

[@EasyMedicalDevice]

Thanks ruba, really appreciated

[@arunthomas7863]

Great session and very useful

[@EasyMedicalDevice]

Thanks for your support

[@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.

[@premkumar-mc8ez]

Nice 🙂

[@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.

[@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

[@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

[@YePapoteGlobal]

🙏

[@prashantpathak3175]

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

[@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