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35127 Conferences

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

Added by Referral on 2010-11-18

Conference Dates:

Start Date Start Date: 2010-12-17

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

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.

This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems.

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.

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
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