The Universities at Shady Grove
Starting at USD 0
Tue, 23 Sep, 2025 at 08:30 am - Wed, 24 Sep, 2025 at 04:30 pm (GMT-04:00)
The Universities at Shady Grove
9630 Gudelsky Drive, Rockville, United States
Understanding the measurement of particle size distribution is crucial when developing methods for quality control and when demonstrating bioequivalence for complex generic drug products. However, development, optimization, and validation of these methods can be challenging due, in part, to the apparent and deceptive simplicity of particle size analysis.
This two-day workshop will include discussions during the performance of hands-on, step-by-step procedures demonstrating how techniques can be performed in a manner that considers all relevant perspectives and enhances our collective understanding on the topic.
Attendees will gain theoretical and practical knowledge relevant to performing particle size measurements across diverse and challenging products like emulsions and suspensions. In-person attendees will interact directly with academic experts, instrument vendors, and regulators to delve into use cases, best practices, and limitations of particle sizing methodologies. Specifically, the workshop will focus on common particle sizing techniques such as dynamic light scattering and laser diffraction, common deficiencies and challenges encountered during quality assessments, bioequivalence studies, and manufacturing process evaluations.
Info: This session provides a comprehensive overview of DLS technology, exploring its fundamental principles and practical applications in particle size analysis. Industry and regulatory scientists will delve into the current challenges associated with analyzing and assessing particle size studies, particularly in the context of supporting regulatory approvals. The session will also cover critical aspects of method validation and highlight common deficiencies observed in regulatory submissions, offering valuable insights for both researchers and industry professionals.
Info: In this session, seven DLS instrument vendors will present rapid-fire overviews of their latest technical developments and measurement best practices. These presentations will focus on innovative solutions to overcome common issues in particle sizing. Speakers will discuss critical considerations that guide users in selecting and operating DLS equipment effectively, providing real-world examples to illustrate the context of use.
Info: This hands-on session offers in-person attendees a unique opportunity to work directly with DLS equipment vendors. Participants will be divided into small groups, rotating through demonstrations of suitable particle size study procedures. Vendor representatives will guide attendees through the intricacies of method development, highlighting common pitfalls and how to avoid them. This practical experience will provide invaluable insights into the nuances of different DLS systems and their applications in complex generic drug development.
Info: In this collaborative session, attendees will work in small groups to tackle real-world challenges in particle size analysis. Guided by experienced moderators, participants will engage in in-depth discussions on multiple topics including measurement considerations, method development, method transfer, validation strategies, data analysis techniques and reporting. For each topic, there will be 50 minutes within small group table discussion followed by 30 minutes report out/discussion with the entire in-person audience.
Info: This session provides a comprehensive introduction to LD technology, exploring its theoretical foundations and practical applications in particle size analysis. Expert speakers will delve into the current challenges associated with LD-based particle size studies, offering insights into best practices and potential pitfalls. Attendees will gain a deeper understanding of LD principles, enabling them to make informed decisions when selecting and implementing this technology in their research or industrial settings.
Info: Industry leaders will share their experiences and insights on the challenges faced in developing generic products, with a focus on particle size measurement. Speakers will discuss critical aspects such as technology selection, method development, and validation processes. The session will also explore the emerging role of artificial intelligence and machine learning in knowledge management for regulatory submissions. A key component of this session will be a discussion on potential hurdles in preparing submission packages and areas where additional FDA guidance could be beneficial, fostering a productive dialogue between industry and regulatory perspectives later in the workshop.
Info: This session mirrors the format of Session 2, focusing on LD technology. Four LD instrument manufacturers will deliver presentations highlighting their latest technical developments and measurement best practices. These talks will address common challenges in particle sizing and offer innovative solutions. Speakers will discuss critical factors that guide users in selecting and operating LD equipment effectively, providing practical examples to illustrate real-world applications. The session will conclude with a panel discussion, allowing attendees to engage with experts and explore the topics covered in greater depth.
Info: Similar to Session 3, this hands-on session provides in-person attendees with the opportunity to work directly with LD equipment manufacturers. Participants will rotate through small group demonstrations, gaining practical experience with various LD systems. Vendor representatives will guide attendees through suitable particle size study procedures, highlighting the strengths and considerations of each system. This session aims to deepen participants' understanding of LD technology and its application in complex generic drug development.
Info: The final session of the workshop begins with vendor-led discussions on pre-workshop sample measurements, including cyclosporine ophthalmic emulsions, phytonadione injections, iron sucrose injection, triamcinolone injectable suspensions, and microcrystalline cellulose. Vendors will share challenges encountered during these measurements and propose solutions. Participants will then engage in small group discussions, collaborating on particle size method development, validation, and data analysis. 50 minutes within small group table discussion, 30 minutes report out/discussion with the entire in-person audience.
Info: The workshop will conclude with a comprehensive summary of key lessons learned and a forward-looking discussion on addressing identified challenges in the near future, setting the stage for continued progress in the field.
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Tickets for Mastering Particle Size Analysis: Techniques and Best Practices can be booked here.
| Ticket type | Ticket price |
|---|---|
| In-Person Attendees (General) | 350 USD |
| In-Person Attendees (Government) | 150 USD |
| Virtual Attendees | Free |
| In-Person Attendees (Government)-Day 1 | 75 USD |
| In-Person Attendees (Government)-Day 2 | 75 USD |
