QbD / PAT/Modeling approach to understand and control your processes: a specific case for tabletting

30 minutes webinar to demonstrate how QbD, PATs and Modeling are three integrated approaches to implement with a specific case for tableting, and 30 minutes for questions & answers.

QbD / PAT / Modeling Objectives: To understand and control the manufacturing process to control the drug product in Development and Production for the benefit of the Patient.

The combined QbD / PAT / Modeling approaches applied with pragmatism, experience and with specific tools, will allow the following :

1. To guide Product Development.
2. To follow the Critical Quality Attributes (CQA) in real time, without being destructive and on a more representative sample.
3. To increase understanding of critical sources of variability and their impact on the finished product, and to promote their control:
4. Raw materials: identification, mean particle size, water content, polymorphism.
5. Blending: blend uniformity, water content.
6. Wet granulation: mean particle size, water content, polymorphism, blend uniformity.
7. Drying & Milling: water content, end point and signature, mean particle size, polymorphism, blend uniformity.
8. Compression: water content, identification, uniformity of content, hardness, porosity, disintegration, dissolution at a specific time.
9. To facilitate the validation exercise of the manufacturing process and the preparation of the dossier,
10. To guarantee the state of control in Production.

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What can you learn from this webinar:

1. How to understand and define the critical sources of variability and links to DP CQAs with QbD
2. How to implement efficiently PAT at different steps of the process with PAT
3. How to detect the presence and degree of variability with PAT
4. How to understand the impact of variability on the process and ultimately on DP CQAs with QbD
5. How to manage, reduce and control variability in a manner commensurate with the risk it represents to the process and product with PAT