Quality Risk Management ICH Q9(R1)

[@muralig5272]

Dear sir, I learned from your video lot of things (process validation, equipment qualification, cleaning validation etc) it's very useful my career, I have gained knowledge day by day.till am learning risks assessment,etc..,,,. Thank you very much sir

[@hitendrakumarshah3718]

All the best. Please keep learning

[@jayapaulgottimukkala5287]

53:46 In proactive based Risk assessment, how to determine the risk score for the probability of occurrence. As the hazard is new there won’t be any past instances . Can we give as 0 in those cases while calculating RPN.

[@hitendrakumarshah3718]

You can not give zero in case of past instances. In case of new things, you can get the information based on - other site information, development and other areas.

[@rahultupe2301]

11

[@maasanjana]

Well presented, sir. Thank you for your efforts to educate the pharma community.

[@hitendrakumarshah3718]

Its my pleasure. Please keep learning !!!

[@MohammadDawdieh]

15:41 The first step in the risk assessment should be Hazard identification instead of risk identification e.g.,. In the overview of a typical QRM Figure , a terminology change as referred to by quality risk management Q9(R1) Final version Adopted on 18 January 2023. It is as follows: “Changing the risk management process from risk identification to hazard identification”.

[@hitendrakumarshah3718]

Very nice. You are correct. Thank you.

[@babjigubbala85]

Thank you sir for a very simple explanation of very complicated subject

[@hitendrakumarshah3718]

Thanks. Please keep learning !!!

[@susheelashenoy2651]

Thank you sir for your efforts to make us understand the guideline requirement in common language. This video is really helpful. 🙏🙏🙏

[@hitendrakumarshah3718]

Thanks. Please keep learning !!!

[@Mohammed-mw8wg]

Excellent presentation sir. Thank you very much indeed

[@hitendrakumarshah3718]

Welcome

[@hitendrakumarshah3718]

@Diego Rafael Monterroza Hernandez ​We need focus on thing can go wrong during the manufacturing process and not in the sampling process during validation. Of course, we need to perform separate risk assessment of sampling activity

[@smarikapanwar9300]

Very well explained Sir, Thanks for updating us.

[@hitendrakumarshah3718]

Always welcome

[@hitendrakumarshah3718]

@Srinivasulu Bhavanasi ​The severity can be reduced by making change in the product manufacturing

[@nitindubey6170]

Excellent explanation ❤

[@hitendrakumarshah3718]

Thank you for your kind comment. Please share this link with your colleagus so that, they can also get benefit from the video learning.

[@ArunThakur-qf5th]

Very good information sir, send one more presentation on cleaning validation and APQR

[@hitendrakumarshah3718]

You can go through below links for these topics - kzbin.info/www/bejne/sHKYqaaNh558i5o kzbin.infomFC3XNes-pA?feature=share kzbin.info2I_H5SsTSuQ?feature=share kzbin.infozBLqRZ5DXV4?feature=share

[@hitendrakumarshah3718]

@amit gupta ​The risk can be reduced.

[@sandipjedhe724]

Any example tobe mentioned to understand

[@hitendrakumarshah3718]

You can through the link - kzbin.info/www/bejne/e5jOnGl3pK-GrMksi=MBFRo7cWLw1cNFFp

[@surajsinghbhandari6]

I love your vedios sir. thanks for such like vedios

[@hitendrakumarshah3718]

So nice of you

[@v.nagasrilakshmiswaroopa7204]

I couldn't able to find the link in the description for practical application of FMEA

[@hitendrakumarshah3718]

Hi, you can go through the link for practical example - kzbin.info/www/bejne/e5jOnGl3pK-GrMk

[@v.nagasrilakshmiswaroopa7204]

Thank you so much sir!!!!

[@ashokchowdary623]

Can you please differentiate the risks while performing the functional risk assessment for the software as part of CSV and risk assessment made while new instrument coming to facility and can a new server and what type of risk assessment is performed while shifting the server from one location to another location types of risk can you please elaborate

[@hitendrakumarshah3718]

The FRA - focusses on the risks related to the computerised system functioning. Means what are the possibility of functionalities go wrong. While in other cases, you need to evaluate all.

[@mayurkale5357]

Good sir... Keep it up 💯

[@hitendrakumarshah3718]

Keep watching

[@maheshsaglawe]

Great session sir

[@hitendrakumarshah3718]

Thank you for your kind comment.

[@smarikapanwar9300]

Sir,Can you please conduct training on ICH Q6

[@hitendrakumarshah3718]

Sure

[@shashishekhar4090]

Nice and thanks

[@hitendrakumarshah3718]

Welcome

[@SonuYadavBawaliya1]

Good evening sir

[@hitendrakumarshah3718]

Thank you for your kind wishes...

[@KB-sg4qi]

30 Min substance

[@hitendrakumarshah3718]

Your question is not clear.