Youtor
Deviations A Practical and Compliance View
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=xuijsumCDnI
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 Management ICH Q9(R1) • Link for QRM - Basics - • Quality Risk Management
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