Pharmaceutical Process Scale-Up

הרשמה מוקדמת במחירים מוזלים 

הרשמה מוקדמת עד ה-14 בנובמבר 2015

הרשמה החל מה-15 בנובמבר 2015

1,485 ש"ח + מע"מ

1,750 ש"ח + מע"מ

תאריך: 24 נובמבר 2015
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 1,750 ש"ח + מע"מ, עד 14 בנובמבר 1,485 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 15930
שפת הקורס: אנגלית
על הקורס

The course is devoted to the principles of pharmaceutical process scale-up and practical application of scientific approach to batch size changes and technology transfer. It discusses the general ideas of the so-called dimensional analysis and looks at a number of case studies. General review of scale-up for unit operations involved in manufacturing is presented and discussed. In particular we are looking at various aspects of scale-up in such unit operations as mixing, fluid bed and high-shear granulation, roller compaction, extrusion and spheronizing, compaction and tableting, encapsulation, and film coating.

קהל היעד

Formulators, process engineers, validation specialists and quality assurance personnel and production managers will find a source of information on batch enlargement technique.

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.

Pharmaceutical Process Scale-Up
התועלת שתופק

By the end of the course, participants will

  • 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
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Introduction
    • Scale-up for pharmaceutical manufacturing industry in the 21st century
    • Regulatory concerns, guidance, directives and regulations
    • Risk Analysis and Process Validation
  • Dimensional Analysis Theory
    • Overview and definitions
    • Relevance list
    • Matrix transformation
    • Dimensionless numbers and how to use them
  • Scale-Up of Unit Operations
    • Parenteral Drugs, Non-Parenteral Liquids and Semisolids
    • Biotechnology-Derived Products
    • Dry Blending and Mixing
    • Fluid Bed Granulation
    • High-Shear Granulation
    • Roller Compaction
    • Extrusion and Spheronizing
    • Compaction and Tableting
    • Capsule Formulations
    • Film-Coating Process

אודות המרצה

ד"ר מיכאל לוין

Dr. Levin has over 30 years of experience in the field of pharmaceutical technology, scale-up, instrumentation and process optimization. Has edited a “Pharmaceutical Process Scale-Up” book, and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology.
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