Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - FDA Webinar By ComplianceOnline (December 17, Friday 10:00 AM PDT | 01:00 PM EDT)

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:  ComplianceOnline provides 20% Discount on any Second purchase of Webinar
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