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
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
• Learn how to overcome scale-up challenges for various unit operations
Course Outline:
• Scale-up for
• Regulatory concerns, guidance, directives
• 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
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.