PDA Europe Virtual Training Course - Optimize Your Freeze Drying Process

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