Lyophilization Technology Effective Design of The Process

OVERVIEW:  
During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs.

Product Id : 501171

Instructor : Jerry Dalfors

Thursday, March 23, 2017   |   10:00 AM PST | 01:00 PM EST   |   Duration: 90 Minutes

WHY SHOULD YOU ATTEND: 
The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. The long term training sessions include participants in development, operations, engineering, technical services, quality, validation, and regulatory affairs. 

AREAS COVERED IN THE SESSION:

Essentially a brief discussion about each of the Critical Aspects and related affects of Variables

• Lyophilization 101 - Comprehension on each step of the Freeze Drying/Lyophilization Process
• Understanding why various steps of the process become more advantageous and cost effective
• Sublimation Rate Variability
• Heat Transfer
• Loss of Protein Activity
• Freezing Affects on Primary Drying
• Optimization of Primary Drying and Proof of the effectiveness of Secondary Drying
• Effects of Freezing Method and Excipients on Protein Surface
• Influenceof Packing Density and the container
• Residual Moisture Regulatory Considerations by the FDA

WHO WILL BENEFIT:

• Compliance Manager
• Process Engineer
• Validation Manager
• Regulatory Manager

SPEAKER PROFILE:
Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.

Others Details

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