Biography
Biography: Chris Wubbolt
Abstract
This presentation will provide an overview of current regulatory requirements and guidance pertaining to data integrity. The presentation will review FDA, MHRA and other regulatory guidance related to data integrity. Approaches to performing data integrity assessments will be discussed and examples from audits and regulatory observations will be reviewed. Implementation of data integrity programs will also be reviewed. The following topics will be discussed at the conference: Review current regulatory data integrity requirements and guidance; approaches to conduct audits / assessments of data integrity programs; examples of data integrity observations and audit findings and; implementing data integrity programs.