Control and Determination of Visible and Sub-visible Particulate Matter in Biologics
Regulations direct drug product manufacturers to exclude foreign matter and minimize foreign particle content. Particles can originate from the environment, packaging materials, formulation ingredients, interactions between product and packaging, or be inherent to the product. For inherent species, or the expected formulation-related particle species, which techniques may be most appropriate? This workshop will be a forum for discussing the control and determination of undesired visible and sub-visible particulate matter and also characterization of inherent particle species in biopharmaceuticals.
- Gain insight into the USP standard process and how to work with USP to impact future standards.
- Obtain feedback about the current chapters and where gaps exist for future standard work.
- Identify areas where USP can broaden our scope in the biologics space.
Who Should Participate?
- Analytical chemists and biologists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Workshop Steering Committee
- Scott Aldrich, Ultramikro, LLC
- Mohammad Heidaran, U.S. Food & Drug Administration
- Ewa Marszal, U.S. Food & Drug Administration
- Anthony Mire-Sluis, AstraZeneca
- John Shabushnig, Insight Pharma Consulting LLC
- Darin Weber, Medeor Therapeutics
- Wesley Workman, Pfizer
- Earl Zablackis, Sanofi Pasteur
- Kevin Carrick, USP
- Desmond Hunt, USP
- Maura Kibbey, USP
Call for Abstracts
Interested in submitting an abstract for the workshop? We want to hear from you! Click here for topics and submission instructions.
Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the “Register” button. Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks, and a lunch and a networking reception.
Registration fees for this workshop have been set as follows:
Regular Fee Per Person
Academia /Association Participant
Student (Full-time; valid I.D. required)
Advance Registration Deadline
Advance registration will be available through June 21, 2017 After that date, registration will be available on site at the USP Meetings Center.
When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).
Cancellation and Substitution Policy
Cancellation must be received on or before June 5, 2017 via email to email@example.com Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to firstname.lastname@example.org
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Please contact email@example.com or +1 301-816-8130.
Local Area Information
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