Ensuring Data Integrity: A Multi-Disciplinary Approach

The FDA Agency investigations and audits of the regulated industries have spent much of their recent focus in the area of Data Integrity and the possible falsification of documents and the improper recording of significant data. In fact, numerous citations have been issued to companies for the manner in which they are or have been treating the recording of pertinent data. Although on many occasions, the personnel involved in these infractions are not aware of the shortcomings of their work, in some cases the FDA inspectors’ interpretation can lead to the belief that a Falsification of data may have occurred. This intensive one-day course will help professionals in the FDA regulated industries with steps on how to avoid such common mistakes. The course will include the investigators perspective and will teach tactics to successful internal audit procedures to keep your company compliant. What to do when Data Integrity issues are found will also be addressed. Several Data Integrity case studies involving both deliberate falsification and improper data recording that SUGGESTS Falsification will be discussed.