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Seminar: Symptoms to an Undesired Path
Date: August 29, 2008
Time: 8:30 am to 4:00 pm
Place: ISS Corp.
We may insist that everything is OK within our operations but could it be possible we may be heading to serious non-compliance situations? Join us to learn how to identify and address the early symptoms!
Review the regulated environment as described by ICH, WHO, FDA
Discuss FDA’s Systems-Based Inspections Technique (QSIT)
Gain additional insight into the four key elements considered in FDA’s Quality System Model (QS)
Identify symptoms leading to a non-compliant working environment
Tools to improve your company readiness for a regulatory inspection
Overview of the phases for a successful Regulatory Inspection
Target Audience
This program will benefit: Regulatory Affairs, QA/QC, Production, Validation, Training, Documentation, Human Resources.
RSVP - (787)625-1500 x 145, fax: 787-783-4214, or dcarrero@isspr.com |
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