Modernization of USP Packaging Standards for Glass and Elastomeric Components

June 19, 2017 - June 20, 2017

Overview

Overview: 

Glass and elastomeric materials used in packaging systems must be shown to be suitable for their intended applications. To address these issues, USP is revising two existing USP-NF chapters <381> Elastomeric Closure for Injections and <660> Containers−Glass and proposing three new chapters <1381> Evaluation of Elastomeric Components Used in  Pharmaceutical Packaging/Delivery Systems, <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems and <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems.

Objectives

This two-day workshop will address the following: 

  • Key issues surrounding USP’s requirements for materials of construction for pharmaceutical packaging systems (glass, elastomers, and beyond)
  • USP’s proposed revision to General Chapter <381>
  • Regulatory expectations regarding the suitability of glass components and systems used for pharmaceutical drug products 
  • USP’s proposed revision to General Chapter <660>
  • Regulatory expectations regarding the suitability of elastomeric components and systems used for pharmaceutical drug products
  • USP’s proposed  General Chapters <1381>, <382> and <1382>

Why Attend?

  • Learn about USP proposals surrounding biocompatibility testing, chemical characterization, and risk-based testing strategies
  • Help shape the future revision of <381> Elastomeric Closure for Injections and <660> Containers−Glass
  • Hear the rationale behind the proposed new chapters, <1381>, <382> and <1382>
  • Help shape the final version of <382>, <1382> and <1381>

Who Should Participate?

  • Research and development scientists, engineers, toxicologists
  • Contract research organizations
  • Contract manufacturing organization
  • Regulatory affairs professionals
  • Quality assurance/quality control professionals

Related Chapters

Registration Information

Regular Price Information: 

Advance Registration Deadline

Advance registration will be available through June 15, 2017. After that date, registration will be available on-site at the USP Meetings Center.

Please note that registering for a USP event requires an Access Point account. If you do not have an account, please follow the instructions after clicking the ‘REGISTER’ button.

Pricing Information

Registration is payable by credit card only.  Registration fees for this workshop have been set as follows:

Participant Type

Fee Per Person
 

Academic/Association Participant

$575

Government Participant

$250

Industry Participant

$675

WebEx/Virtual Participant

$325

Student Participant

$150


Registering Others

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 May 29, 2017 (21 days prior to the event) via email to conferences@usp.org. 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 conferences@usp.org.

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees. However, once registered USP will provide a registration confirmation that may be utilized to obtain a visa. You may request this confirmation by contacting conferences@usp.org

Registration Questions

Please contact conferences@usp.org or +1 301-816-8130.

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8136