Modernization of USP Packaging Standards for Glass and Elastomeric Components
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.
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>
- 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
- Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems <1663>
- Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664>
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.
Registration is payable by credit card only. Registration fees for this workshop have been set as follows:
Fee Per Person
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 firstname.lastname@example.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 email@example.com.
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 firstname.lastname@example.org
Please contact email@example.com or +1 301-816-8130.