| 00:00:00 | Introduction |
The Mastersizer 2000 laser diffraction particle size analyzer reaches the end of its supported life in April 2022.
If you are a Mastersizer 2000 user, you need to act now to plan your upgrade and safeguard your method transfer activities.This is a great opportunity to verify approved methods for Mastersizer 2000 and plan its transfer to the Mastersizer 3000. During verification, it is essential to assess correlation between obtained results, using laser diffraction and microscope investigation. Following method transfer, you must assess if the process can be completed with the same parameters, or if any changes should be implemented. Of course, adjusting the method during transfer requires appropriate justification for regulatory authorities, and should be correctly reported.
In this webinar, guest presenter Maria Sobusiak, a researcher working in the pharmaceutical industry, will share her experience of particle sizing method transfer for commercial active pharmaceutical ingredients (APIs). This will cover the theory of the technique and guidelines in practical use to reach an appropriate course of action during method transfer and to advance substantively justified variations to the regulators.
演讲嘉宾
Maria Sobusiak
Maria Sobusiak works as Preformulation Projects Senior Specialist at Polpharma, where she is responsible for leading specialized research and development work in preformulation. 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 forpharmacy students on the subjects of supplier qualification processes and powder characteristics inpharmacy, 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.
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Who should attend?
- Researchers working on method transfers
- Specialists responsible for method changes in the regulated environment
What will you learn?
- Learn how to transfer your method and report changes appropriately
- Understand which areas require special attention to correctly verify your method
- Understand when validation is required and how to apply best practice
- Learn how to report parameter changes to the regulatory authorities