DIA 48th Annual Meeting
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ICH Update on Pharmaceutical Quality
Track : Track 12: Pharmaceutical Quality
Program Code: 115
Date: Monday, June 25, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Elaine Morefield, FDA, United States
PRESENTER (S):
 Betsy Fritschel, Johnson & Johnson, United States
 Elaine Morefield, FDA, United States
 John Kauffman, FDA, United States
Description
This forum will discuss ICH topics related to pharmaceutical quality, including the new guideline for drug substances (Q11) and the Q8, Q9, and Q10 points to consider document.

Learning Objectives:
Describe the scope and content of recent ICH documents related to quality
Discuss Q11 for drug substances, Q3D for metal impurities and the quality implementation groups points to consider documents.



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