ICH Q9 Guidance for Quality Risk Management | With simplified example

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  • Опубліковано 4 жов 2024

КОМЕНТАРІ • 34

  • @drvica7633
    @drvica7633 5 місяців тому

    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!

  • @SateeshKumarSingh-we9jv
    @SateeshKumarSingh-we9jv 5 місяців тому

    Great easy way to understand ich q9

  • @PrakashParmar-kd6lg
    @PrakashParmar-kd6lg Рік тому +1

    This single presentation is enough for QRM. Good

  • @prady654
    @prady654 9 місяців тому

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

  • @sonykannidi7699
    @sonykannidi7699 2 роки тому +3

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

    • @proftalks1680
      @proftalks1680  2 роки тому

      Thanks. Will work on suggested topic..

  • @rajtigris
    @rajtigris 11 місяців тому +1

    Very well presented! Thanks ProfTalks

  • @sowndaryam2491
    @sowndaryam2491 Рік тому

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

  • @VijayKumar-hu7ou
    @VijayKumar-hu7ou 10 місяців тому

    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

  • @mohitjhansi
    @mohitjhansi 6 місяців тому

    Lage raho bhai outstanding effort

  • @anirudhnandan85
    @anirudhnandan85 Рік тому +1

    Good explanation.. great effort

  • @munasofi5037
    @munasofi5037 Рік тому +1

    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
      @proftalks1680  Рік тому

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

  • @tilahunalemayehu1498
    @tilahunalemayehu1498 Рік тому +1

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

    • @proftalks1680
      @proftalks1680  Рік тому

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

  • @achyutjagdhane9683
    @achyutjagdhane9683 Рік тому +1

    thanks a lot sir , very nice

  • @deepakjaiswal3988
    @deepakjaiswal3988 2 роки тому +1

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

    • @proftalks1680
      @proftalks1680  2 роки тому

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

  • @VijayKumar-hu7ou
    @VijayKumar-hu7ou 10 місяців тому

    Good information sir

  • @madhan5577
    @madhan5577 Рік тому +1

    Phama example is there means good to understand

    • @proftalks1680
      @proftalks1680  Рік тому

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

  • @bhavanigandi3859
    @bhavanigandi3859 Рік тому

    Please do vedio in QRM tools

  • @kannanmuthusamy4787
    @kannanmuthusamy4787 Рік тому +1

    Plz share ppt too hence text not clear/ hazy

    • @proftalks1680
      @proftalks1680  Рік тому

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

  • @teeders48
    @teeders48 Рік тому

    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
      @proftalks1680  Рік тому

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

  • @Shyam0024
    @Shyam0024 2 роки тому +1

    Risk assessment of new equipment in pharma company

    • @proftalks1680
      @proftalks1680  2 роки тому

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

  • @mansisinha1
    @mansisinha1 2 роки тому +1

    It should be ISO 31000 : 2018