USP–U.S.
12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130
Overview
Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, plastic assemblies also elicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety. Evaluation of such plastic materials/systems and their potential impact remains a challenge for suppliers and end-users. USP's Packaging and Distribution Expert Committee is developing a practical and science-based approach for the qualification of plastic materials used in the manufacture of medicinal products.
Objectives
- Engage stakeholders and provide background on USP’s effort to develop a standard for plastic components and systems used in the manufacturing process, which builds off existing plastic standards.
- Discuss current challenges and strategies for qualifying plastic manufacturing components.
Why Attend?
- Hear the rationale behind the proposed new chapter, <665> Plastic Materials, Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products.
- Be a part of the discussion that will shape the final version of General Chapter <665>.
- Learn about the proposed new General Chapter <1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products which supports <665>.
- Understand current successes and challenges with qualification of plastic manufacturing components within the pharmaceutical industry.
- Learn strategies and techniques being used for Extractables and Leachables studies on plastic manufacturing components.
Who Should Participate
- Research and development scientists, engineers, toxicologists
- Contract research organizations
- Contract manufacturing organizations
- Regulatory Affairs
- Quality Assurance/Quality Control specialists
Participant Resources
- <661.1> Plastic Materials of Construction
- <661.2> Plastic Packaging Systems for Pharmaceutical Use
- <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and
- <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery System
- Recently Posted: <665> Plastic Materials, Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products
- Recently Posted: <1665> Characterization of Plastic Materials, Components and Systems Used in the Manufacture of Pharmaceutical and Biopharmaceutical Drug Products
Registration
Advance registration will be available through Monday, April 15, 2019 at 12:00 PM ET. After that time, registration will be available on-site at the USP Meetings Center.
Pricing Information
Registration is payable by credit card only. Registration fee includes the full one-day program, meeting materials, coffee breaks and lunch. Registration fees for this workshop have been set as follows:
| Participant Type | Regular Fee Per Person (1-2 individuals from the same organization) | Multi-registrant price (3 or more individuals from the same organization; all must register at the same time to receive the discount) |
| Industry | $675 | $600 |
| Academia/association | $575 | $500 |
| Government | $250 | N/A |
| Student | $150 | N/A |
| Virtual | Industry/Association/Academia - $325 Government/Student - $150 |
N/A |
Cancellation and Substitution Policy
Cancellation must be received on or before March 26, 2019 via email to conferences@usp.org. Refunds will not be issued for cancellations received after this date. There is a $50 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 you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa. Registration Questions Please contact conferences@usp.org or +1 301-816-8130.
Hotel & Travel Information
Please note that the headquarter hotel for this workshop is the Cambria Hotel and Suites Rockville. Shuttle service on Tuesday will be provided between USP and the Cambria only. The rate is $157 per night plus tax when you book using the link below by Friday, March 29:
https://www.choicehotels.com/reservations/groups/SG60D2
For information on additional local hotels (please note that transportation on Tuesday will not be offered from any hotel except the Cambria)