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Live Webinar How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare Date: Tue, December 2, 2014 Instructor: Jeff Kasoff
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 60 Minutes
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Overview: During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Areas covered in the session: Documents Used by FDA Inspectors CAPA Implications of Investigations Operations Manual (IOM), and Recommended Methods of Compliance for each Requirement CAPA Implications of CPG Manual 7382.845, and Recommended Methods of Compliance for each Requirement QSIT Manual: Description of each CAPA Inspectional Objective, and Recommended Methods of Compliance
Who Will Benefit: R&D Management Regulatory Management QA Management Consultants Quality System Auditors
About Speaker Jeff Kasoff Director of Regulatory Affairs, LifeTech, Inc Jeff Kasoff RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices,
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