Deviations - A Practical and Compliance View скачать в хорошем качестве

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 Management ICH Q9(R1)   Link for QRM - Basics -   • Quality Risk Management