Plenary Session: Data Integrity

Hear from members of the Part 11 Task Team on data integrity issues

Description

The FDA has concerns about data integrity and if your data can be trusted. This Plenary will bring all three tracks together and help you learn how you can prove to the FDA that your data is accurate.

How You Will Benefit

At the conclusion of this session, participants will be able to:

• Understand the concerns of regulators in relation to issues of data integrity, new technologies, and risk-based validation

Speakers

• George Smith, Compliance Officer, FDA, USA
• Sion Wyn, Director, Conformity Ltd., UNITED KINGDOM