

EVENT OVERVIEW:
FDA warning letters and 483 observations provide valuable information that can be used to show trends in FDA regulatory focus and changes in auditing practices. Data Integrity has dominated FDA pharmaceutical warning letters in recent years and has harmonized regulators all over the world through common training, exchange of information, and collaboration. Analysis of FDA warning letters, 483 information, and other regulatory noncompliance data provides a more complete picture of regulatory actions and trends in FDA auditing practices. Laboratories can leverage this insightful regulatory data to understand evolution of FDA thinking and be better prepared for their next FDA audit.
Join compliance expert Paul Smith as he reviews where to find valuable non-compliance data, how to use the data to identify insights, and trends in FDA auditing practices.
KEY LEARNING OBJECTIVES:
PRESENTER:
Paul Smith
Global Strategic
Compliance Specialist
Agilent Technologies
WHO SHOULD ATTEND:
Sponsored by Agilent CrossLab. Presented by LC / GC.
For questions contact Kristen Moore at kristen.moore@ubm.com