Online MasterClass 05-08 September, 2023

Particle Size
Characterization - US edition
MasterClass

Maria Sobusiak

Learning outcomes:

• Method development
• Multi-tech method transfer
• Method validation (ICH Q2)

Time Zone: • Method changes to the regulatory authorities

Eastern Daylight • Particle size of the API in product development

• API supplier qualification and cooperation
Time (EDT)
• Material properties vs laser diffraction method
- UTC−04:00

www.glceurope.com
Particle Size Characterization 05-08 September, 2023
- US edition MasterClass Online MasterClass

EVENT INTRODUCTION

Course explores various approaches to particle size and shape characterization requirements
for active pharmaceutical ingredients (APIs) during oral solid dosage product development -
from the method development, through validation and registration process to the changes in
requirements and audit. Also, it brings the knowledge about importance of different material
properties in particle size assessment. Finally, the course broaden mind on business aspects
like suppliers qualification, development costs and optimization of working conditions.

Who Should Attend?

• Researchers working in pharmaceutical research and development

• Specialists responsible for method development
• Scientists involved in QC release analysis
• Pharmaceutical scientists working in preformulation and formulation
• Researchers working on method transfers
• Specialists responsible for method changes in the regulated environment EU

Methodology

The participants will gain knowledge via lecture-type sessions, letting time for Q&A and discussions.
Furthermore the training places great emphasis on practical examples through case studies.

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booking@glceurope.com +36 1 848 0515
Particle Size Characterization 05-08 September, 2023
- US edition MasterClass Online MasterClass

Meet the Trainer:

Maria Sobusiak
Preformulation Projects Senior Specialist
Pharmaceutical Works Polpharma S.A.

Maria Sobusiak is Preformulation Projects Senior Specialist, responsible for leading specialized
research and development work. She focuses on the study of powder characteristics and
particle size and shape assessment using laser diffraction methods having regard to different
material properties. Maria also delivers trainings, workshops and webinars for pharmaceutical
industry on the topic of particle size analysis as guest expert of Malvern Panalytical and
cooperates with the Medical University of Gdańsk delivers seminars for and workshops for
students as preparation for the work in the industry.

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booking@glceurope.com +36 1 848 0515
Particle Size Characterization 05-08 September, 2023
- US edition MasterClass Online MasterClass

All dates and times are expressed in Eastern Daylight Time

(EDT) on the Agenda - UTC−04:00

We reserve the right to make slight adjustment in the training program

day 1 day 3
08:55 Connecting to the Online MasterClass 08:55 Connecting to the Online MasterClass
09:00 Particle size of the API - 09:00 Laser diffraction method
size and shape assessment - validation and qualification
theory and practice • Qualifications vs validation
• Methods of the particle size assessment • Requirements
• Results comparision in reference to • Accuracy of the methods
different methods of analysis • Guidelines
• Errors of measurements • Acceptance criteria
• Laser diffraction in particle size • Validation Master Plan
distribution analysis - theory • Results reporting

10:15 Coffee Break 10:15 Coffee Break

10:45 Particle size distribution by laser 10:45 Particle size methods
diffraction - method development multi-tech transfer
• Equipment preparation • Requirements
• Method development: dry and wet dispersion • Types of the transfer
• Errors of measurements • Design space
• Critical parameters • Guidelines
• Reliability of the results • Leading of the transfer
• Conditions of transfer prosecuting
• Documentation
12:00 END End of day 1 • Acceptance criteria

12:00 END End of day 3

day 2 day 4
08:55 Connecting to the Online MasterClass 08:55 Connecting to the Online MasterClass
09:00 Method transfer: 09:00 Registration aspects
Mastersizer 2000 to Mastersizer 3000 • Documentation preparation during:
• Imaging - optical microscopy and SEM product development
• Optical properties • Change of the technique of the particle
• Powder flow size assessment
• Solubility • Equipment change (M2000 to M3000)
• Polymorphysm • Types of changes
• Influence on the product • Lead time
• Processing stability
• Dissolution 09:50 Audit
• Content uniformity • Results interpretation
• Paying attention to the measurements
10:15 Coffee Break and its quality data
• Documentation
10:45 API in product development • Raw data
• How to lead research
• Sites included 10:40 Coffee Break
• Supplier selection
• Design space 11:10 Case study
• Analytical method development
• Batch-to-batch control and scale-up 12:00 Feedback/Evaluation session
• Guidelines

12:00 END End of day 2 12:10 END End of day 4

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booking@glceurope.com +36 1 848 0515
Particle Size Characterization 05-08 September, 2023
- US edition MasterClass Online MasterClass

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