Thorough and Complete Investigations and Follow-up - A Current Regulatory Expectation 2013

Key Topics

• FDA expectations for investigations and observations
• What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances
• Tools for understanding the process - mapping, critical incident, performance matrix
• The investigation/problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success
• Tools for narrowing the investigation to the cause - data collection, data analysis
• Tools for understanding the possible causes - brainstorming, is/is not, nominal group
• Corrective action
• Tools for determining the root cause - cause and effect, Fault tree, 5 Whys
• Verification
• Preventive Action

Who should Attend

• QA personnel responsible for reviewing investigations reports
• QA document reviewers
• Quality and Operations personnel responsible for investigations
• QA personnel responsible for the deviation and investigations systems
• Personnel from all units responsible for initiating investigations