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Process Scale-Up & QbD Principles in Pharma

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Key topics

Application of Quality by Design Principles during Process Development and Scale-Up

Scale-Up and Process validation

Practical approaches for Scale-Up of the Wet and Dry Granulation and the Compression Process

Meaningful application of PATs

Common Scale-up issues and troubleshooting

Integrating material science concepts in drug product development to simplify formulation and speed up process development

Application of stability simulations to identify shelf life-limiting Quality Attributes and complement real time stability studies

Takeaways & Special Features

Understand

• Industry approaches for scaling-up of solid dosage forms applying QbD principles

Learn

• How to translate theoretical scale-up models and current regulatory guidances into practice – What is really relevant?

 

Gain

• Knowledge of formulation, process transfer and validation for commercial drug production. Practical knowledge during the interactive sessions and workshops

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Delegate Fee

from 2196 € Buy

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Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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Leonardo Royal Hotel Munich

Moosacher Straße 90, 80809 Munich, Germany

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