Wednesday 3rd April, 2013
10:00am to 11:30am
Overview: The presentation will cover important documents such as the Establishment Inspection Report, and the FDA Notice of Observations. The presentation will also cover the different steps the investigator takes after he/she finishes the inspection and writes the Establishment Inspection Report in the various programs used by the agency to track inspection reports and regulatory considerations.
Why should you attend: You should attend to inform yourself and staff on how the evidence is collected by FDA investigators and how it is reviewed by several agency departments and what actions are taken as a result of the reviews. Learn to be ahead of the process and take effective steps to minimize the impact of the inspection or take effective corrective action to rectify your compliance status with the agency.
Areas Covered in the Session:
Law/Regulations of Inspections
Logistics of Inspections
Evidence Collection in an Inspection
Sample Collections and the Processing of Samples for Regulatory Actions
Notifications of Actions to FDA Import Operations for Import Alert Considerations
Who Will Benefit:
Regulatory Affairs Directors/Managers/staff
Quality Assurance/Control staff
Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/10bM3iY
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3rd April 2013