Thorough and Complete Investigations and Follow-up - A Current Regulatory Expectation 2013 is a webinar that covers topics such as:
- 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
Thorough and Complete Investigations and Follow-up - A Current Regulatory Expectation 2013 is intended for:
- 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
