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

IQ OQ PQ are 3 pillars of Process Validation. IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance Qualification. Before you even get to IQ, OQ, PQ, if you're acquiring a new piece of equipment, you'll need design specifications that define exactly what's in that piece of equipment
⏱️ 𝑻𝒊𝒎𝒆 𝑺𝒕𝒂𝒎𝒑 ⏱️
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0:00 - Introduction
- What is required in IQ, OQ & PQ.
- FDA guidelines on IQ OQ PQ as per 21CFR 820.75 and as per ISO13845
- Why do we to validate a process?
- IQ OQ PQ process Flow
- Input/ Output of each IQ OQ PQ.
📖 𝐁𝐞𝐬𝐭 𝐁𝐨𝐨𝐤 𝐨𝐧 𝐀𝐦𝐚𝐳𝐨𝐧 ( 🎭 𝐌𝐮𝐬𝐭 𝐑𝐞𝐚𝐝 )
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🚩 𝐖𝐨𝐫𝐥𝐝’𝐬 𝐆𝐫𝐞𝐚𝐭𝐞𝐬𝐭 𝐁𝐨𝐨𝐤𝐬 𝐅𝐨𝐫 𝐏𝐞𝐫𝐬𝐨𝐧𝐚𝐥 𝐆𝐫𝐨𝐰𝐭𝐡 & 𝐖𝐞𝐚𝐥𝐭𝐡
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🚩 𝐁𝐞𝐠𝐢𝐧𝐧𝐞𝐫'𝐬 𝐆𝐮𝐢𝐝𝐞 𝐭𝐨 𝐋𝐞𝐚𝐧 𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚
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- 𝐔𝐒𝐀 users Click Here to Buy : amzn.to/3xGojaQ
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🚩 𝟕 𝐇𝐚𝐛𝐢𝐭𝐬 𝐨𝐟 𝐇𝐢𝐠𝐡𝐥𝐲 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐏𝐞𝐨𝐩𝐥𝐞
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- 𝐔𝐒𝐀 users Click Here to Buy : amzn.to/3z3uh5N
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🚩 𝐋𝐞𝐚𝐧 𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚 𝐚𝐧𝐝 𝐌𝐢𝐧𝐢𝐭𝐚𝐛 - 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐠𝐮𝐢𝐝𝐞
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- 𝐔𝐒𝐀 users Click Here to Buy : amzn.to/3z65RZL
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🚩 𝐋𝐞𝐚𝐧 𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚 𝐅𝐨𝐫 𝐃𝐮𝐦𝐦𝐢𝐞𝐬
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- 𝐔𝐒𝐀 users Click Here to Buy : amzn.to/3r9o1Hc
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🚩 𝐋𝐞𝐚𝐧 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐒𝐢𝐦𝐩𝐥𝐢𝐟𝐢𝐞𝐝: 𝐖𝐨𝐫𝐥𝐝'𝐬 𝐌𝐨𝐬𝐭 𝐏𝐨𝐰𝐞𝐫𝐟𝐮𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐒𝐲𝐬𝐭𝐞𝐦
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- 𝐔𝐒𝐀 users Click Here to Buy : amzn.to/3ilTovi
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📢📢 📢📢 𝐅𝐨𝐥𝐥𝐨𝐰𝐬 𝐮𝐬 𝐨𝐧 𝑺𝒐𝒄𝒊𝒂𝒍 𝑴𝒆𝒅𝒊𝒂
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𝐂𝐨𝐦𝐦𝐨𝐧 𝐊𝐞𝐲 𝐬𝐞𝐚𝐫𝐜𝐡 𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐭𝐨 𝐭𝐡𝐢𝐬 𝐭𝐨𝐩𝐢𝐜 :
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#medicaldevices #IQOQPQ #21cfr #Digital_e_Learning #ProcessValidation #21CFR820 #FDA #510k #ISO14971 #ISO13485

[@shannon9287]

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

[@DigitalELearning]

Thanks Shannon 😊

[@DigitalELearning]

👀 Hello Friends, 𝐉𝐨𝐢𝐧 my 𝑺𝒐𝒄𝒊𝒂𝒍 𝑴𝒆𝒅𝒊𝒂 𝑳𝒊𝒏𝒌 for regular updates:
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🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚 (𝟔σ ) : whatsapp.com/channel/0029VaEWKWbIiRovZpAduc0p
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🙋🏻‍♂𝐖𝐡𝐚𝐭𝐬𝐀𝐩𝐩 (𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞 & 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥) :whatsapp.com/channel/0029VaAKJBGKGGGDjcK4mw2h

[@Seebzters]

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

[@wilfredocardona2795]

Great! Thank you.

[@DigitalELearning]

✌

[@nehakakkar2286]

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

[@DigitalELearning]

Thanks Neha 😎

[@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!

[@cvilla1035]

Thank you for the presentation , really helpfully 😊

[@DigitalELearning]

My pleasure 😊 Cecilia

[@adamshill3958]

Heart of Medical Industry

[@DigitalELearning]

Thanks 😎

[@venkataramreddybhairi489]

nice , thank you..

[@DigitalELearning]

✌

[@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 :)

[@trangduongyen8309]

Thank you so much

[@DigitalELearning]

Thanks 😎

[@abhilashkothari9730]

Thank you Aman

[@DigitalELearning]

✌😎

[@asdsfgg1235]

thanks sir ji

[@DigitalELearning]

✌

[@vikasmehra5397]

Thank You

[@DigitalELearning]

✌

[@nguyenvuong7243]

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

[@DigitalELearning]

Okay

[@ramakrishnaguttula7941]

Good information

[@DigitalELearning]

Thanks

[@markben4449]

Very nice one

[@DigitalELearning]

Thanks 😎

[@gagandpkr]

Thanks for sharing

[@sudhirpatange8585]

Very helpful right now I am working in shilpa

[@DigitalELearning]

Thanks

[@danielpina7225]

thank you.

[@DigitalELearning]

You're welcome Daniel

[@jayamanideepravipudi7244]

Tq brother

[@DigitalELearning]

Thanks 😎

[@bhawnachawla5540]

Thanks

[@DigitalELearning]

Thanks

[@sumitchaudhary571]

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

[@DigitalELearning]

Thanks

[@salmanbaghwaan7076]

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

[@gollapalligangadhar1099]

Tq

[@DigitalELearning]

Glad you enjoyed it!

[@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?

[@nguyenhieu6129]

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

[@DigitalELearning]

Sure Feedback noted

[@kailasravdeshmukh463]

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

[@DigitalELearning]

Thanks 😎

[@parvizparviz1597]

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

[@ngoctrungo1541]

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

[@DigitalELearning]

Klay

[@tokram7779]

How come here for their job.. please like

[@DigitalELearning]

Thanks

[@hemantbramhne4435]

DQ?

[@DigitalELearning]

Yes, DQ is also there.

[@jaizontee6951]

you need to clarify the content

[@DigitalELearning]

Feedback noted

[@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

[@praveenkumarchoudhary6584]

plz Hindi me baniye video

[@DigitalELearning]

Thanks 😎 Sure

[@lanhuong5951]

CovidImages need to be invested more than half19

[@DigitalELearning]

Okay 👍