Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - FDA Webinar By ComplianceOnline

Start/End: 12-17-201012-17-2010

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admin 650-620-3915 admin@complianceonline.com
Event Website Event Type
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product... Web Event

Event Information

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 this promocode(111087) to get 10% Discount,Valid till Dec 20th.

Address Information (get map)

Address City State Zipcode Country
2600 E. Bayshore Road Palo Alto None. 94303 USA

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