Extractables & Leachables

Extractables & Leachables
December 9, 2013 - December 10, 2013
REGISTER

Overview

Co-sponsored by: : 
PQRI and USP
Overview: 

Currently, USP and PQRI have extractables and leachables efforts, with plans to have a document in the public domain by late 2013. Thus, the purpose of this workshop is to bring stakeholders together to discuss and collect feedback on the new standards and recommendations by both organizations.

Objectives: 

The purpose of the Extractables and Leachables Workshop is to present, discuss, and get stakeholders’ feedback on new extractables and leachables standards and recommendations:

  1. USP
    1. <661> Packaging Systems: Plastic Materials of Construction
    2. <661.1> Plastic Packaging Systems for Pharmaceutical Use
    3. <1663> Determination of Extractables Associated with Pharmaceutical Packaging Systems
    4. <1664> Good Manufacturing and Stability Practices—Assessment of Leachable Associated with Pharmaceutical Packaging
  1. PQRI
    1. Safety Thresholds and Best Practices for Extractables and Leachables in Parenterals and Ophthalmic Drug Products
Who Should Participate: 

This workshop is intended for all stakeholders (industry, regulators, and associations) interested in characterizing and measuring these molecules in biotechnology products. This includes professionals working in or with:

  • Research and development
  • Contract research organizations
  • Contract manufacturing organizations
  • Regulatory affairs
  • Quality assurance/quality control

For additional information, email us at conferences@usp.org or call +1-301-816-8136.

Agenda

application/msword iconAgenda

Registration Information

Regular Price Information: 
  • Industry—$895
  • AAG—$695
Early Discount Information: 
  • Industry—$795
  • Academia/Association/Govt. (AAG)—$595
Early Registration Deadline: 
October 25, 2013
Group Discount Information: 

Three or more attendees from the same company:

  • Industry—$695 per person
  • AAG—$495 per person
Other Registration Information: 
  • Student (must present valid student ID)—$150

Registration fee includes full two-day program, meeting materials, continental breakfast and lunch each day, and a networking reception. Contact conferences@usp.org for details.

USP Headquarters
12601 Twinbrook Parkway
Rockville, MD 20878
United States
Phone: +1-301-816-8136
See map: Google Maps
Javascript is required to view this map.