Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity has been a requirement for years, recently there has been an increased focus on this topic both from a regulatory and industry perspective and Data Integrity has been the focus of numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations. In addition, more guidelines and regulations have been published to establish Data Integrity Standards.

As Data Integrity programs mature, we need to transition from a reactive mode to a preventative mode and engrain Data Integrity into our Quality Management System and Culture. This conference will be comprised of interactive case studies, presentations, and roundtable discussions.

Learning Objectives

At the completion of this event, attendees will be able to:

• Understand the current regulatory climate and remediation expectations and to define what is needed to engrain Data Integrity into the Quality Management System and Culture.
• Promote a holistic understanding of the challenges faced by the industry in data integrity
• Discuss strategies on how to utilize Quality Risk Management to prevent Data Integrity issues and establish a quality culture which promotes Data Integrity as a core value.

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