Quality Risk Management for Computerised Systems

#pharmaceutical #csv #csa #validation #quality #qrm #riskmanagement #fda #compliance #gmp #ich
This session will make you understand the "Quality Risk Management for Computerised Systems" requirements in line with the various guideline expectations for example - EUGMP annex 11, 21 CFR Part 11, GAMP5 guide etc.
The agenda for this session is as below;
Importance of topic
Know your Trainer
Purpose and Scope of CSV
QRM - Guideline Requirements in Computerised Systems
Quality Risk Management - Overview
Quality Risk Management - Practical Approach
Risk Management to Evaluate Potential Impact
Risk Management within the Validation Lifecycle
Q&A
Vote of Thanks and contact details
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[@Nirmanyujamwal]

great explanation sir. Could you please share the presentation?

[@hitendrakumarshah3718]

I am sharing the presentation during the training session. You can attend our all training programs on every Saturday at 20:00 Hrs. I will share training presentation of that topic at the end of the session.

[@hitendrakumarshah3718]

Dear all, you can download the training presentation from this link:we.tl/t-iL6nvcelWR
Kindly note that, the link will be valid for only 4 days. So, hurry up....

[@kajosa1291]

Hello sir, I really appreciate providing great webnar like this!
By the way, I was just wandering how can we justify our decision of the risk assessment? I mean, inspectors could think our company did not perform the test because of the poor justified reason.

[@hitendrakumarshah3718]

The risk assessment should be done not to reduce the work. But, it is to be done to provide rationale why we are performing specific test? Hope you got the point.

[@kajosa1291]

Thank you, sir! I hope someday I can join your webinar in live 😂😂 ​@@hitendrakumarshah3718

[@etta5383]

Hellos sir, Please share the presentation

[@hitendrakumarshah3718]

Hi, please find herewith link to download the presentation - we.tl/t-tgUZkQQ2tA

[@Mini-is3vs]

Hello Sir,
Could you please share the Presentation

[@hitendrakumarshah3718]

Hi, please find herewith link to download the presentation - we.tl/t-tgUZkQQ2tA

[@hitendrakumarshah3718]

Dear all, you can download the training presentation from this link:we.tl/t-iL6nvcelWR
Kindly note that, the link will be valid for only 4 days. So, hurry up....

[@keyurvora621]

Sir Plz Share This Presentation

[@hitendrakumarshah3718]

Dear all, you can download the training presentation from this link:we.tl/t-iL6nvcelWR
Kindly note that, the link will be valid for only 4 days. So, hurry up....