IQ OQ PQ | Process Validation | Equipment Validation | Equipment Qualification | Medical Devices

[@shannon9287]

Thanks very much! I’m in Procurement, this will help in my meeting later with a supplier! Appreciate the resource.

[@DigitalELearning]

Thanks Shannon 😊

[@iamseebabhatia]

The Medical Device - Risk Management Regulation is ISO 14971. The Medical Device - Quality System Regulation is ISO 13485. The Quality System Regulation is QSR 21 CFR 820. The installation location should be verified, so it meets Good Manufacturing Practices. Installation Qualification is a step-by-step list for the quality assurance of the equipment. Some inputs areDesign Failure and Mode Effect Analysis, Process Failure and Mode Effect Analysis....

[@DigitalELearning]

Seeba, seems you have good experience with in Medical device development

[@playlistajsy4486]

Will you please elaborate each phase of equipment qualification with listed (1) how design protocol, what is the basic approach and require thing to design protocol, reference of protocol design (2) any common considerations in protocol design irrespective of equipment make mechanism function etc. Eg. Safety, risk assessment, challenge studies, product runs like that are any more. (3) what we have to do if we observed non intrensic failures of equipment qualification (4) how to schedule calibration, preventive maintenance (5) how we can recommend preventive maintenance, in what way, what we need, and references of preventive maintenance etc etc

[@adastra123]

Thank you , a course I am doing did not explain it well , you did a great job thank you .

[@DigitalELearning]

Glad it was helpful!

[@sumitchaudhary571]

Very useful information for me. Can you please update how can i write a test for OQ and PQ/

[@DigitalELearning]

Thanks

[@nguyenhieu6129]

You try to give the video more brightness it will be great if you do

[@DigitalELearning]

Sure Feedback noted

[@cvilla1035]

Thank you for the presentation , really helpfully 😊

[@DigitalELearning]

My pleasure 😊 Cecilia

[@adamshill3958]

Heart of Medical Industry

[@DigitalELearning]

Thanks 😎

[@nguyenvuong7243]

Very good and funny videos bring a great sense of entertainment!

[@DigitalELearning]

Okay

[@IK-qu9hw]

Very nice. I am instrumentation engineer 2017 batch. After completion of degree I started working in automation field ( I have done oq ,pq of blender, RMG ,FBD machine also 21 cfr part 11 with end client. ) now I have 1 yr experience in automation field.since salary package is very less so now I am thinking to switch to pharma sector, I have one question what should I do now shall I switch to pharma or not? Plz reply..

[@DigitalELearning]

Pharma and Medical Devices sector is growing at Rapid pace and has food scope in future as well... All the best

[@IK-qu9hw]

@@DigitalELearning so sir in which department I can apply. Like there are many department documentation, production...

[@nokwandadlamini1929]

Pharmaceutical manufacturing in production will be most in line with what you’re experienced in. Hope you made the leap of faith?

[@gagandpkr]

Thanks for sharing

[@sudhirpatange8585]

Very helpful right now I am working in shilpa

[@DigitalELearning]

Thanks

[@rickjoseph8451]

Great work! this video contains useful information and excellent animation to explain the concept.

[@DigitalELearning]

Thanks

[@andresbrodie5086]

pro tip: watch series at Flixzone. I've been using them for watching lots of of movies these days.

[@christopheronyx4671]

@Andres Brodie yea, I've been using flixzone} for since december myself :)

[@gollapalligangadhar1099]

Tq

[@DigitalELearning]

Glad you enjoyed it!

[@vikasmehra5397]

Thank You

[@DigitalELearning]

✌

[@markben4449]

Very nice one

[@DigitalELearning]

Thanks 😎

[@nehakakkar2286]

Thank you.. Very informative video . keep it upi . Just love your youTube channel :)

[@DigitalELearning]

Thanks Neha 😎

[@abhilashkothari9730]

Thank you Aman

[@DigitalELearning]

✌😎

[@asdsfgg1235]

thanks sir ji

[@DigitalELearning]

✌

[@ramakrishnaguttula7941]

Good information

[@DigitalELearning]

Thanks

[@kailasravdeshmukh463]

Thank you sir,,, pharma code kase nikale solution batao

[@DigitalELearning]

Thanks 😎

[@bhawnachawla5540]

Thanks

[@DigitalELearning]

Thanks

[@wilfredocardona2795]

Great! Thank you.

[@DigitalELearning]

✌

[@salmanbaghwaan7076]

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

[@ngoctrungo1541]

the video image is too poor, you need to fix it more

[@DigitalELearning]

Klay

[@parvizparviz1597]

Your headline is wrong. They present a qualification process. A Process Validation (PV) is carried out after completion of qualification of production line.!

[@trangduongyen8309]

Thank you so much

[@DigitalELearning]

Thanks 😎

[@venkataramreddybhairi489]

nice , thank you..

[@DigitalELearning]

✌

[@DigitalELearning]

👀 Hello Friends, 𝐉𝐨𝐢𝐧 my 𝑺𝒐𝒄𝒊𝒂𝒍 𝑴𝒆𝒅𝒊𝒂 𝑳𝒊𝒏𝒌 for regular updates: ------------------------------------------------------------------------------------------------------------------ 📸𝐈𝐧𝐬𝐭𝐚𝐠𝐫𝐚𝐦 : instagram.com/digital_elearning/ 🐦𝐓𝐰𝐢𝐭𝐭𝐞𝐫: twitter.com/DigitalELEARNI1 📢𝐓𝐞𝐥𝐞𝐠𝐫𝐚𝐦 : t.me/digital_e_learning007 🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐋𝐞𝐚𝐧 𝐬𝐢𝐱 𝐬𝐢𝐠𝐦𝐚) : whatsapp.com/channel/0029VaAUuqs4inooet3e4S3O 🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚 (𝟔σ ) : whatsapp.com/channel/0029VaEWKWbIiRovZpAduc0p 🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐒𝐭𝐚𝐭𝐢𝐬𝐭𝐢𝐜𝐬 & 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡) :whatsapp.com/channel/0029VaAGwzTDJ6H9S5Q4Ow0m 🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭) :whatsapp.com/channel/0029Va8slQdEAKWAhXoQK13B 🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞 & 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥) :whatsapp.com/channel/0029VaAKJBGKGGGDjcK4mw2h

[@hemantbramhne4435]

DQ?

[@DigitalELearning]

Yes, DQ is also there.

[@jayamanideepravipudi7244]

Tq brother

[@DigitalELearning]

Thanks 😎

[@jaizontee6951]

you need to clarify the content

[@DigitalELearning]

Feedback noted

[@tokram7779]

How come here for their job.. please like

[@DigitalELearning]

Thanks

[@riserofevil7656]

This would have been easier to understand if Steven Hawking had read it to us.

[@DigitalELearning]

I will make a video to explain this in a better way

[@lanhuong5951]

CovidImages need to be invested more than half19

[@DigitalELearning]

Okay 👍

[@praveenkumarchoudhary6584]

plz Hindi me baniye video

[@DigitalELearning]

Thanks 😎 Sure

[@danielpina7225]

thank you.

[@DigitalELearning]

You're welcome Daniel