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Data Integrity Workshop - Level 4 - Copenhagen, Denmark

  • Hotel SKT Petri 22 Krystalgade København, 1172 Denmark (map)

This 2-day workshop provides the unique opportunity to learn valuable forensic review and investigative / inspection-readiness techniques from a former FDA Drug Investigator with globally-recognized expertise in data integrity investigations. In this workshop, you will have the chance to share ideas with other experienced GxP personnel in small-group, hands-on inspection case study exercises as each team applies their data integrity inspection skills in mock inspection scenarios, building upon the learnings from Level 3 and providing additional case studies in preparation for a ‘Data Integrity Auditor’ qualification exam.  Highlights include:

  • Detecting Patterns in Analytical Data

  • Detecting Potential Falsification During Paper-Based Reviews

  • Remote Review of Records with an Eye for Breaches in Data Integrity

  • Evaluating Quality Culture and What It All Means

  • Advanced Interviewing Techniques

  • Detecting Data Integrity Risks in the Manufacturing Environment

  • Aspects of an Effective Six-System Risk-Based Inspection

  • Preparing Responses to Data Integrity-Related Health Authority Observations

  • More Case Studies

The Level 4 workshop is taught by Peter Baker, former FDA Drug Investigator, with specialized global expertise in data integrity investigations. This workshop is designed for experienced personnel who have completed the GMQA Levels 1 through Level 3 workshops and have a minimum of 5 years of GxP experience.  The Level 4 workshop may be of particular interest to Quality Auditors, including Forensic Auditors, as well as personnel from all-functions responsible for preparing for Health Authority inspections and responding to data integrity-related observations.

Earlier Event: September 18
PDA-FDA Data Integrity Conference