ICH Q9 Guidance for Quality Risk Management | With simplified example

[@drvica7633]

Thank You so much, greeting from México, it was a very useful example for a Work Medicine class, Im a First Year resident of this speciality, and that example works a lot, than you!

[@PrakashParmar-kd6lg]

This single presentation is enough for QRM. Good

[@proftalks1680]

Thank you very much for kind words

[@rajtigris]

Very well presented! Thanks ProfTalks

[@proftalks1680]

Thank you🙏

[@prady654]

i should really appreciate the way it was explained, big thanks.

[@sowndaryam2491]

The best presentation for QRM... Pls explain QRM tools sir... Thank you

[@sonykannidi7699]

Nice presentation...very informative...i need root cause analysis with examples...

[@proftalks1680]

Thanks. Will work on suggested topic..

[@SateeshKumarSingh-we9jv]

Great easy way to understand ich q9

[@mohitjhansi]

Lage raho bhai outstanding effort

[@anirudhnandan85]

Good explanation.. great effort

[@proftalks1680]

Thanks🙏

[@VijayKumar-hu7ou]

Sir ,diring traing you mention we can take pharmaceutical issue as an example plese make one more video ,so that we can understand in depth.thank you sir

[@munasofi5037]

very nice presentation. would you please let me know what kind of risk management measures a company would need if it outsources all of it's manufacturing activities?

[@proftalks1680]

Thanks.. Please share your email id.. I will write some description of the requirements.

[@tilahunalemayehu1498]

The presentation is very helpful and practical, thanks. But i dont get the video u mentioned about FMEA. Is there any video?

[@proftalks1680]

Thank you for appreciation. I have actually not yet loaded the separate FMEA presentation, but surely will do so at the earliest.

[@VijayKumar-hu7ou]

Good information sir

[@achyutjagdhane9683]

thanks a lot sir , very nice

[@proftalks1680]

Thanks for supporting

[@deepakjaiswal3988]

Nice informative video,Please speak loudly sir during next.thanks

[@proftalks1680]

Thanks Deepak... Noted and will implement...

[@bhavanigandi3859]

Please do vedio in QRM tools

[@madhan5577]

Phama example is there means good to understand

[@proftalks1680]

Thank you for the suggestion. Will take care of the same

[@kannanmuthusamy4787]

Plz share ppt too hence text not clear/ hazy

[@proftalks1680]

Sure, meanwhile the problem can be due to weak internet connection. Please check the same as well

[@Shyam0024]

Risk assessment of new equipment in pharma company

[@proftalks1680]

Hi, please clarify your comment. This will help me make improvement

[@teeders48]

One thing that is missing from this is how to determine the appropriate thresholds for low/medium/high risks. Why is 41 selected as high, etc.? Why is this acceptable? Additionally, the descriptions of qualitative or quantitative are incorrect. You provided two types of qualitative categorization. Just because a number is used does not make is quantitative. ICH Q9 explains a quantitive estimate uses a numerical probability. A scale from 1 to 5 is not quantitative, what are the probability threshold for each category?

[@proftalks1680]

Thank for the review comment. Will check the details against Q9 once more

[@mansisinha1]

It should be ISO 31000 : 2018

[@proftalks1680]

Thanks for value addition..