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Investigation Process 

Hitendrakumar Shah
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This video will help viewers to understand why training on investigation process is required? Further they will understand in brief about types of investigation tools and how to achieve compliance by recording the use of specific investigation tool/s. Also, the viewers will understand the common errors by some persons during the investigation.

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26 янв 2020

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Комментарии : 31   
@prasadtalekar4961
@prasadtalekar4961 3 года назад
Excellent 👌👌
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thanks
@rajuyadavraj7858
@rajuyadavraj7858 3 года назад
Super examples.. Sir..
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thank you for your kind comment
@ChanduInfoVlogs
@ChanduInfoVlogs 4 года назад
Hi sir Tq for u r suggest and I need full part of investigations in quality management system please provide sir
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Sure will conduct training on this topic. Now I am conducting FREE learning sessions. If you are interested you can join our whatsapp group. You can go through the recorded training session in the youtube only under my name. (Hitendrakumar Shah)
@hemantsuryawanshi422
@hemantsuryawanshi422 3 года назад
Really great experience... I was aware only about 5 why, brainstorming and ishikawa tools..really thank u sir. Please keep uploading such quality presentations.
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Sure. Thanks. Keep Learning !!!
@rajeshkunchala5682
@rajeshkunchala5682 2 года назад
Hi sir.while fbd process time if inlet temprature out of limit.how to give capa
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
What is root cause of this incident? To avoid this cause, is CAPA
@sandipgarud5982
@sandipgarud5982 3 года назад
The OOS process is not applicable for In process testing while trying to achieve a process end point i.e. adjustment of process (e.g. pH, Viscosity) and for studies conducted at variable parameters to check the impact of drift (e. g. Process validation at variable parameters) The above statement from MHRA guideline for OOS. What does mean of that whether OOS investigation should be performed or not if results obtained OOS for process validation batches?
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
I suggest you refer FDA guide. It is more clear." As per FDA In certain instances, in-process testing is done solely for purposes of triggering real time equipment or system adjustments to prevent process drift. This guidance does not address these situations". Hope it is clear
@maganti7suresh
@maganti7suresh 4 года назад
Sir...pls provide full scale investigation report in quality control area and provide exmple protocol
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
I suggest, first you please put your efforts. Prepare draft one. then, definitely i will review for you and share my comments for finalisation.
@RAKESHKUMAR-iv7ug
@RAKESHKUMAR-iv7ug 2 года назад
Dear sir, kindly share some example of warehouse incident, deviation
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
Sure. Will do it in separate video
@monap1124
@monap1124 3 года назад
sir, plz explain with case studies
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Ok. Will do it
@bhavna-suthar
@bhavna-suthar 2 года назад
Sir need training of GMP online class so give me your details how to I do that
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
You can get connected with me. Be a subscriber and hit the bell icon. So that, during the training sessions after planning you will get notifications on your RU-vid.
@JC-qu1se
@JC-qu1se 4 года назад
Dear sir Kindly provide investigation procedure for QC
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
You can refer below link for investigation in QC - ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-J3HHycD6rsI.html ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-DU5d_D9CLfw.html If you have further questions, please feel free to put in the comment box.
@harikaharipriya3297
@harikaharipriya3297 3 года назад
Tel the regulatory authorities which are invented investigation tools
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
No regulatory authority expects to follow specific investigation tools. The expectation is to investigate. You can choose suitable tool.
@harikaharipriya3297
@harikaharipriya3297 3 года назад
Incident ref guidelines please define
@harikaharipriya3297
@harikaharipriya3297 3 года назад
Or only tools we have only,
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Please specify your questions with clarity. Do you want to know the ref for incidents?
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Sorry. Not clear with your question.
@jatinpatel8662
@jatinpatel8662 3 года назад
Dear sir I want to know that what is 95% confidence limit for OOT and how it established . Or 3sigma concept for the same I request to you plz arrange training for the same Thanks Jatin
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
For OOT- you can make use of 3 sigma or 6sigma. 95% confidence limit concept is different.
@jatinpatel8662
@jatinpatel8662 3 года назад
Thanks a lot sir Can arrange one training session for 3 sigma and 6 sigma
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