How to transfer methods in multi-site drug development projects

Join pharmaceutical industry expert Maria Sobusiak to explore best practices for transferring laser diffraction particle sizing methods between teams, sites and instruments.

As an active substance moves along the workflow, it may pass between various teams and even between different sites. When changes like this happen, it’s essential to perform an assessment of the robustness and comparability of the analytical methods upon which it depends, and in some cases to carry out a method transfer and validation procedure.

In this webinar, we’ll explore how analytical methods for active pharmaceutical ingredients can be unified between different sites, instruments and teams. Focusing on the Mastersizer 3000 laser diffraction system, Maria will share her experience of multi-site method transfer. This will cover practical guidelines as well as an examination of various approaches for successful transfer and validation.

Speakers

Guest Presented by Maria Sobusiak

Maria Sobusiak works as a Pre-formulation Projects Senior Specialist at Polpharma, where she is responsible for leading specialized research and development work in pre-formulation. Her work is currently focused on the study of powder characteristics and particle size and shape assessment using laser diffraction methods. This is closely coupled with the drug product manufacturing process. Maria is also involved in new raw materials qualification and the registration of variations in terms of particle size method changes.

Maria also cooperates with the Medical University of Gdańsk, where she leads electives for pharmacy students on the subjects of supplier qualification processes and powder characteristics in pharmacy, and she also coordinates the MA thesis program. Since 2019, Maria has been delivering training, workshops and webinars on the topic of particle size analysis.

More information

Who should attend?

  • Researchers working on method transfer for laser diffraction, including those working in R+D, QC and QA
  • Specialists responsible for method changes and validation in the regulated environment

What will you learn?

  • Learn best practice for transferring Mastersizer methods
  • How to ensure the robustness and reproducibility of your analytical method
  • How to implement guidelines for acceptance criteria for method transfer and validation