Mastering Particle Size Analysis:  Techniques and Best Practices
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Mastering Particle Size Analysis: Techniques and Best Practices

Workshop with presentations, panel discussions, and hands-on, step-by-step procedures demonstrating particle size analysis.

By Center for Research on Complex Generics

Date and time

Location

The Universities at Shady Grove

9630 Gudelsky Drive Rockville, MD 20850

Refund Policy

No Refunds

Agenda

8:55 AM - 9:55 AM

Day 1-Session 1: Dynamic Light Scattering (DLS)


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 de...

9:55 AM - 12:15 PM

Day 1-Session 2: Vendor Perspectives for DLS


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 sol...

1:10 PM - 2:40 PM

Day 1-Session 3: DLS Equipment Demonstrations (In-Person Only)


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 s...

2:50 PM - 5:30 PM

Day 1-Session 4: Small Working Group Discussions (In-Person Only)


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 di...

8:40 AM - 9:30 AM

Day 2-Session 5: Laser Diffraction


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 cu...

9:30 AM - 10:30 AM

Day 2-Session 6: Industry Perspectives


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 su...

10:45 AM - 12:25 PM

Day 2-Session 7: Vendor Perspectives for LD


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 b...

1:25 PM - 2:10 PM

Day 2-Session 8: LD Equipment Demonstrations (In-Person Only)


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 demonstrat...

2:10 PM - 3:10 PM

Day 2-Session 9: Small Working Group Discussions (In-Person Only)


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,...

3:20 PM - 4:30 PM

Day 2-Session 10: Waypoint Exercise (In-Person Only)


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...

About this event

  • Event lasts 1 day 8 hours
  • Paid venue parking

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.

Frequently asked questions

Attendee Parking Locations

The Traville-Gateway Garage (Levels 2-6) is the closest parking garage to the event. Attendees may also park in Lot 2 or the Shady Grove Garage but will need to allow more walking time to reach the event. Link for guest parking: https://shadygrove.umd.edu/sites/default/files/u516/TAPS%20PARKI

Attendee Parking Cost

Attendees are responsible for the cost of parking; parking will not be validated. Parking is $16.00 per day.

Virtual Attendance

Virtual attendees will receive a Zoom webinar link for each day. The links will be provided in emails from Zoom (Center for Research on Complex Generics). Virtual attendees will also receive reminders from Zoom, 24 h and 1 h, prior to the start of the event with the respective links.

Continuing education (CE) credits

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

Organized by

The Center for Research on Complex Generics (CRCG) facilitates research collaborations that help increase access to safe and effective generic drugs.

$0 – $350