Deviations - A Practical and Compliance View

Are you still categorizing deviations based on examples in SOP?
Are your deviations SOP lacking for controls on repeat deviations?
Do you need to understand more about deviation trending?
Do you need to focus on effective writing of deviation?
If the answer to any of the above questions is “Yes”, this training session is for you.
Join this channel to get access to the perks:
/ @hitendrakumarshah3718
This session will help you learn many aspects of Deviations - A Practical & Compliance View
The training agenda is as below;
Brief introduction of the concept
Know your Trainer
Guideline expectations about
deviations- EU,FDA, ICH, ANVISA, ISO etc.
Detailed understanding about deviations
Scientific way for categorization of deviations -Simplified risk assessment tool in line with WHO recommendations.
Categorization strategy for repeat deviations
Effective writing of deviations
Trending - Points need to consider
Q&A session
Link for QRM - ICH Q1A(R2) - • Quality Risk Managemen...
Link for QRM - Basics - • Quality Risk Management

[@mayursarolkar]

Please provide material

[@hitendrakumarshah3718]

Hi, the training material is shared during the LIVE training. After that, I can not share it.

[@ratnaramyaatyam5874]

In howa many days deviation need to close?

[@hitendrakumarshah3718]

Normally, as industry practice, it is 30 days. However, you may change based on deviation.

[@ratnaramyaatyam5874]

Please share training copy sir

[@hitendrakumarshah3718]

I am having training copy only during the live training session. After that, I will not have it. All live sessions are on wednesday and Saturday. The link is prepared and shared to attendees. See you on coming live session.

[@prabhatsharma6138]

please provide pdf sir

[@hitendrakumarshah3718]

Hi, I have shared during the LIVE session. Hope you attended the LIVE session.

[@sunilthakur-yb9cq]

Please share Training PDF

[@hitendrakumarshah3718]

Hi, I am sharing training PDF during the training only. Here in comments, there is no possibility to attach PDF. Please check with your colleagues who attended the learning on that day. They can share with you.

[@sunilkumargnv8354]

Hi Sir
Is investigation tool and RCA tool both are same , could please elaborate in regulatory aspects
And how to select these tools also
Thank you sir

[@hitendrakumarshah3718]

Really nice question. For your answer, I will be organising separate session on Investigation tools Vs RCA Tools. The session will be on 9th March. Thank you for suggesting good topic.

[@sunilkumargnv8354]

@@hitendrakumarshah3718 Thank you Sir

[@hitendrakumarshah3718]

@@sunilkumargnv8354 welcome. For this, I raised poll on this in WhatsApp group