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9-2 - Reverse Engineering 483s and Warning Letters to Improve Your QA Program 
April 18, 2016   3:45pm - 4:45pm
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Each year the FDA's BIMO inspection program issues about 300 FDA form 483s and 10-15 Warning Letters to clinical investigators. These documents contain a wealth of information that can inform clinical investigators where the pitfalls of compliance are. Research professionals can leverage this wealth of information to inform and drive their Quality Assurance programs to best effect. This session will start with an update on the latest BIMO metrics with a close examination of findings for Clinical Investigators and their common origins. Then samples of 483s and Warning Letters will be subjected to critical analysis, from which areas of focus for Quality Improvement programs will be derived.

Learning Objectives:
  1. Identify most common findings in BIMO inspections through review of current metrics.
  2. Recognize common failures in responses to 483s through a critical review of recent Warning Letters. Extrapolate these common findings and responses to identify critical areas of focus in a site QA program.

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CDER BIMO Compliance and Enforcement: What You Need to Know!
Advanced Monitoring Visit Documentation: Global Regulatory Authority Inspections and Sponsors
2016 Update: U.S. Healthcare Changes and How They Affect the Clinical Research Industry