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How FDA Trains Its Investigators to Review CAPA,
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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. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
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. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
Session Highlights
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Documents Used by FDA Inspectors
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Operations Manual (IOM)
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CAPA Implications, by Section
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Requirements
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Recommended Methods of Compliance for Each Requirement
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CPG Manual 7382.845
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CAPA Implications, by Section
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Requirements
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Recommended Methods of Compliance for Each Requirement
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QSIT Manual
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Description of each CAPA Inspectional Objectives
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Description/explanation
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Recommended Methods of Compliance
Who can Benefit
The employees who will benefit include:
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R&D Management
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Regulatory management
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QA management
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Consultants
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Quality system auditors
Speaker Details
Instructor Profile
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management.
Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671
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