As of July 1st, 2016, 360 Performance Circle has become
Kaizen Online, a part of Kaizen Institute

KI

FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 09
Corrective and Preventive Actions
Video Length:
ID# DTA109
Price:
$145.00

Disk 9 of 10  (54 minutes)

You can buy the individual disks, or you can buy the complete training set for a 30% savings. 

CD of one of ten training sessions

Outline

  • Purpose of the corrective and preventive subsystem
  • Introduction
  • Nonconforming product 21 CFR § 820.90
  • Definition:  product
  • Controlling nonconforming product
  • Evaluating nonconforming product
  • Preamble:  notification re nonconforming product
  • Review and disposition of nonconforming product
  • Documenting disposition of nonconforming product
  • Preamble:  concessions
  • Preamble:  more on concessions
  • Procedures for rework
  • Documenting rework
  • Corrective and preventive action 21 CFR § 820.100
  • CAPA procedures
  • Definition:  corrective action
  • Definition:  correction
  • Definition:  preventive action
  • Preamble:  CAPA procedures
  • Data analysis
  • Data sources for CAPA analysis
  • Examples of internal data sources
  • Examples of external data sources
  • Use statistical methodology
  • Investigate to determine root cause
  • Preamble:  investigations
  • Preamble:  more on investigations
  • Identify corrective and preventive actions
  • Preamble:  degree of corrective and preventive actions
  • Preamble:  user error
  • Verify/validate corrective and preventive actions
  • Preamble:  verification and validation
  • Implement corrective and preventive actions
  • Types of actions to correct problems
  • Example of correction
  • Example of corrective action
  • Example of preventive action
  • Situation analysis:  The Case of the Stretchy Tubing
  • Communicating CAPA information
  • Management review of CAPA information
  • Preamble:  CAPA activities for management
  • Documenting CAPA activities
  • Inspecting CAPA activities
  • CAPA activities & effective QS
  • Preamble:  availability of CAPA information
  • Preamble:  more on availability of CAPA information
  • Summary

System requirements

  • Windows XP (Service Pack 3), 7, 8
  • Internet Explorer 6 or later
  • Note:  This program will not run in Chrome, Firefox, or Safari.  It will not run on a Mac.  
DTA logo Produced for and in collaboration with the Dental Trade Alliance

 You can buy the individual disks, or you can buy the complete training set for a 30% savings.