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2020 Freeze Drying

PDA Europe Virtual Training Course - Optimize Your Freeze Drying Process

Using Analytical, Visual and Mechanistic Approaches

Oct 15, 2020
2:00 PM
-
5:00 PM
| Central Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe

Overview

This training course provides an overview of typical critical quality attributes (CQAs) of freeze-dried products, and why it is crucial to assess these at each stage of development to aid in the development of a suitable freeze-drying formulation and manufacturing process. It will examine several different types of analysis that can be applied to the liquid material prior to freeze drying, after reconstitution and also the freeze-dried material. By understanding the CQAs of a freeze-dried product and identifying appropriate analytical techniques, methodologies such as quality by design (QbD) can be applied in the development process. By doing so, a high level of quality control and consistency can be achieved in the final product, which can limit batch to batch variation. Other methods such as in-process analytical techniques (PAT) will also be demonstrated and provide an understanding on how to apply these to optimizing the manufacturing process for the freeze-dried product. This will be an interactive training course which will include a practical exercise in which the participants will assess products in vials and relate their observations to the freeze-dried product, formulation and freeze-drying cycle

Agenda

  • Thursday, 15 October 2020


    14:00 CEST
    Welcome, Opening Remarks


    Introduction to Freeze-Drying


    Overview

    • Typical Critical Quality Attributes of a Freeze-Dried Product
    • Analytical Methods and Approaches for Freeze-Dried Products and Case Studies
    • Process Analytical Technology used in Monitoring Primary Drying 

    Assessing Structural Properties of Freeze- Dried Products


    MicroPress: Novel Technique in Measuring Mechanical Properties of Freeze-Dried Products 


    17:00
    End of Course

Trainers

Andrew Bright
Andrew Bright
Biopharma Process Systems

Learning Objectives

  • Learn about typical CQAs in freeze dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.
  • Gain a basic understanding of typical analytical techniques that can be applied to freeze dried products.
  • Recognize the value of analytical assessment for freeze dried products to aid in the development of products and the manufacturing process using quality by design.
  • Learn to visually assess freeze dried products and understand what factors affect their appearance, structure and physical properties

Who Should Attend

  • R&D Scientists
  • Formulation Scientists
  • Product & Process Scientists/ Managers
  • Quality Control departments

Registration Fees

Register Now
Registration Type Price
All Participants €400

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