Quality Risk Management ICH Q9(R1)

Рет қаралды 11,351

Жыл бұрын

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This training session help viewers to learn -
Brief introduction of the topic and scope
Brief on ICH Quality Guidelines
Understanding guideline for Quality Risk Management
Updates in new version of guideline ICH Q9 (R1)
Understanding of - Managing your risk has its own rewards.
Role of ICH Q9 with ICH Q8 and ICH Q10
Practical understanding on QRM process and how to perform QRM by FMEA tool.
Action Priority Tablet concept/Heat map matrix
Vote of Thanks - Q&A session
If you need an example for how to use FMEA tool - Go through the link of video (10 minutes duration). At the last - I have given the practical example.
Link: • Quality Risk Management

Пікірлер: 42

@maasanjana Жыл бұрын

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

@hitendrakumarshah3718 Жыл бұрын

Its my pleasure. Please keep learning !!!

@susheelashenoy2651 Жыл бұрын

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

@hitendrakumarshah3718 10 ай бұрын

Thanks. Please keep learning !!!

@babjigubbala85 Жыл бұрын

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

@hitendrakumarshah3718 10 ай бұрын

Thanks. Please keep learning !!!

@smarikapanwar9300 Жыл бұрын

Very well explained Sir, Thanks for updating us.

@hitendrakumarshah3718 Жыл бұрын

Always welcome

@Mohammed-mw8wg 11 ай бұрын

Excellent presentation sir. Thank you very much indeed

@hitendrakumarshah3718 11 ай бұрын

Welcome

@nitindubey6170 7 ай бұрын

Excellent explanation ❤

@hitendrakumarshah3718 6 ай бұрын

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

@hitendrakumarshah3718 Жыл бұрын

@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

@surajsinghbhandari6 Жыл бұрын

I love your vedios sir. thanks for such like vedios

@hitendrakumarshah3718 Жыл бұрын

So nice of you

@MohammadDawdieh 9 ай бұрын

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 8 ай бұрын

Very nice. You are correct. Thank you.

@maheshsaglawe Жыл бұрын

Great session sir

@hitendrakumarshah3718 Жыл бұрын

Thank you for your kind comment.

@shashishekhar4090 3 ай бұрын

Nice and thanks

@hitendrakumarshah3718 2 ай бұрын

Welcome

@hitendrakumarshah3718 Жыл бұрын

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

@ArunThakur-qf5th 9 ай бұрын

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

@hitendrakumarshah3718 9 ай бұрын

You can go through below links for these topics - kzfaq.info/get/bejne/sKdlq9aIt5-thWw.html kzfaq.infomFC3XNes-pA?feature=share kzfaq.info2I_H5SsTSuQ?feature=share kzfaq.infozBLqRZ5DXV4?feature=share

@mayurkale5357 8 ай бұрын

Good sir... Keep it up 💯

@hitendrakumarshah3718 8 ай бұрын

Keep watching

@hitendrakumarshah3718 Жыл бұрын

@amit gupta The risk can be reduced.

@jayapaulgottimukkala5287 9 ай бұрын

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 8 ай бұрын

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.

@sandipjedhe724 8 ай бұрын

Any example tobe mentioned to understand

@hitendrakumarshah3718 8 ай бұрын

You can through the link - kzfaq.info/get/bejne/e82bnply1LC3pps.htmlsi=MBFRo7cWLw1cNFFp

@SonuYadavBawaliya1 Жыл бұрын

Good evening sir

@hitendrakumarshah3718 Жыл бұрын

Thank you for your kind wishes...

@v.nagasrilakshmiswaroopa7204 Жыл бұрын

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

@hitendrakumarshah3718 Жыл бұрын

Hi, you can go through the link for practical example - kzfaq.info/get/bejne/e82bnply1LC3pps.html

@v.nagasrilakshmiswaroopa7204 Жыл бұрын

Thank you so much sir!!!!

@ashokchowdary623 Жыл бұрын

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 Жыл бұрын

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.

@smarikapanwar9300 Жыл бұрын

Sir,Can you please conduct training on ICH Q6

@hitendrakumarshah3718 10 ай бұрын

Sure