Boston Professional Events List


FDA Trains Its Investigators to Review CAPA, What You Can do to Prepare Complaint Handling in Compliance with FDA and ISO Regulations


Date
Mar 12, 2019 - 01:00 PM - 02:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
Florida,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

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

  • Documents Used by FDA Inspectors

  • Operations Manual (IOM)

  • CAPA Implications, by Section

  • Requirements

  • Recommended Methods of Compliance for Each Requirement

  • CPG Manual 7382.845

  • CAPA Implications, by Section

  • Requirements

  • Recommended Methods of Compliance for Each Requirement

  • QSIT Manual

  • Description of each CAPA Inspectional Objectives

  • Description/explanation

  • Recommended Methods of Compliance


     

 

Who can Benefit
The employees who will benefit include:

  • R&D Management

  • Regulatory management

  • QA management

  • Consultants

  • Quality system auditors



Speaker Details


Instructor Profile

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. 

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected] 

Event Categories
Keywords: pharmaceutical




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