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Dimensional Analysis for Scientific Scale-Up

4434
Duration : 90 Minutes

Michael Levin,

Michael Levin, Ph.D., has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology. His most recent book Read more


This webinar will be devoted to the principles of pharmaceutical process scale-up and practical application of scientific approach to batch size changes and technology transfer. We will be discussing the general ideas of the so-called dimensional analysis and look at a number of case studies. General review of scale-up for unit operations involved in manufacturing will be presented and discussed. In particular we will look at various aspects of scale-up in various solid dosage unit operations.

Course Objectives:

• Understand the theory and practice of scientific scale-up
• Define and apply rigorous methods of new product development to minimize potential scale-up issues
• Know the principles of PAT and how to apply measurements for most effective scale-up
• Recognize how to troubleshoot production problems attributed to improper scale-up
• Recognize the relationship between QbD, formulation development and worry-free scale-up process
• Learn how to overcome scale-up challenges for various unit operations

Course Outline:

• Scale-up for pharmaceutical manufacturing industry in the 21st century
• Regulatory concerns, guidance, directives and regulations
• Dimensional Analysis Theory
• Dimensionless numbers and how to use them
• Scale-Up of Unit Operations
          • Dry Blending and Mixing
          • High-Shear Granulation
          • Roller Compaction
          • Compaction and Tableting

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

As a source of information on batch enlargement technique, this course will be of practical interest to

• Formulators
• Process Engineers
• Validation Specialists and Quality Assurance Personnel
• Production managers. 
• Students and practitioners of chemical engineering and pharmaceutical technology will gain a thorough knowledge of scientific basis and practical know-how of product and process scale-up.
• Production floor personnel may find this course beneficial for troubleshooting of manufacturing problems arising from improper scale-up processes or tech transfer. People involved in regulatory compliance who need to follow the guidance for post-approval changes may also benefit from this course.  

No special knowledge of engineering or mathematics (except for simple matrix transformations) will be required from the attendees since any theoretical considerations are fully explained.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Dimensional Analysis for Scientific Scale-Up


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