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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