Preparing for the New Elemental Impurities Guidelines

This webcast will begin on October 14, 2014, 11:00 EDT for North America and October 21, 2014, 15:00 CET for Europe

OVERVIEW

The bio/pharmaceutical industry has long anticipated revised guidelines for elemental impurities limits and testing. While many questions about the final guidelines, as defined in the International Conference on Harmonisation (ICH) in Q3D Guideline for Elemental Impurities and the United States Pharmacopeia (USP) in General Chapters <232> and <233> still remain, organizations should begin to initiate plans to transition to these new guidelines now.

In this webcast, experts from pharmaceutical and excipient manufacturers and analytical testing services will discuss key areas of concern including risk assessment, proposed test methods, and sample preparation techniques. Audience members will have the opportunity to ask questions about the pending implementation.

Key Learning Objectives:

• Review expected requirements for ICH Q3D and USP <232> and <233>
• Understand key areas for risk assessment and factors that affect risk
• Learn appropriate methods and procedures for sample preparation.

SPEAKERS

Katherine Ulman
Vice Chair of Science and Regulatory Policy
IPEC Americas

John Glennon
Stability Lab Team Leader
Supply Chain Stability Testing Hub ZEB Quality
NA, Japan & Global Pharma Supply
GSK

Nikki Schopp
Team Leader
Analytical Laboratory Services
SGS Life Science Services

Moderator
Rita Peters

Editorial Director
Pharmaceutical Technology

IMPORTANT - PLEASE READ
This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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