Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations 2010
17 Dec 2010
Webinar
This webinar addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations.
Areas Covered in the Seminar:
What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances.
FDA expectations for investigations.
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 understanding the process - mapping, critical incident, performance matrix.
Tools for understanding the possible causes - brainstorming, is/is not, nominal group.
Tools for narrowing the investigation to the most probable cause - data collection, data analysis.
Determining the root cause - cause and effect, Fault tree, 5 Whys.
Corrective action.
Preventive Action.
Verification.
Who Will Benefit:
QA document reviewers
QA personnel responsible for reviewing investigations reports
QA personnel responsible for the deviation and investigations systems
Quality and Operations personnel responsible for investigations
Personnel from all units responsible for initiating investigations
Note: Use these promocode for 10% discount (108530) Valid till Dec 20th.
Past Events
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations 2010 - 17 Dec 2010, Webinar (11850)
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations 2026
Important
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