DIA 48th Annual Meeting
Click here to go to the previous page
Auditing Pharmaceutical Quality Systems
Track : Track 12: Pharmaceutical Quality
Program Code: 318
Date: Wednesday, June 27, 2012
Time: 8:00 AM to 9:30 AM  EST
CHAIR :
 Joseph Famulare, Genentech, a Member of the Roche Group, United States
PRESENTER (S):
 Carmelo Rosa, FDA, United States
 Ian Jackson, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Elaine Eborall, Genentech, a Member of the Roche Group, United States
Description
A robust pharmaceutical quality system includes a well thought-out auditing program for self audits of contract manufacturing organizations, suppliers and their distribution chain. This provides senior management key information to ensure quality.

Learning Objectives:
Define auditing practices that are critical to product quality utilizing principles of quality risk management
Describe how auditing practices will help to maintain the control strategy and mitigate risks of adulteration.