Assuring Data Integrity and Current FDA Enforcement Related to Data Integrity Problems

Session Description: FDA has always taken very seriously the integrity of data generated to support drugs consumed by the public. This session will elaborate on FDA’s perspective on data integrity, provide examples of data integrity problems found during inspections, describe areas where FDA may want to probe more extensively during an inspection, discuss the difference between data integrity and the Application Integrity Policy (AIP), explain what data integrity problems can mean for your firm, and how you can resolve data integrity problems. Learning Objectives: • Why is data integrity important • Examples of data integrity problems • Red flags for FDA • How to resolve data integrity problems