Bracketing and Matrixing Designs in

Описание: #stability #ich #pharmaceutical #pharma #fda #shelflife #quality #qualitycontrol
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This training session will take you through an understanding of the ICH Guide, stability study, and its reduction techniques.
The training will include below points;
Brief introduction of the concept, brief strategy
Know your Trainer
Disclaimer or clarification by the guideline
Applicability of reduced design
Bracketing - Design factors, strength and container closure size and/or fills
Example of Bracketing approach
Matrixing - Design factors, test reduction plans
Applicability and degree of reduction
Potential risk with Bracktign and Matrixing Approach
Q&A Vote of Thanks

If you have any question/s, please feel free to raise your questions in the comment section. I will reply to you.

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Link for Brief on Stability Study (ICHQ1A R2) Session :   • Stability Study in Pharmaceutical Industry  

Link for Quality Risk Management ICH Q((R1) -    • Quality Risk Management ICH Q9(R1)  
Link for Brief understanding of Quality Risk Management -    • Quality Risk Management