As of July 1st, 2016, 360 Performance Circle has become
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KI

FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 07
Process Validation; Quality System Requirements and GHTF Guidance
Video Length:
ID# DTA107
Price:
$145.00

Disk 7 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

  • Introduction
  • Quality system regulation
  • Process Validation guidance
  • What is the GHTF?
  • Status of guidance
  • Guidance
  • Process validation requirements
  • Requirement to validate processes
  • Verification definition
  • Process validation definition
  • Product definition
  • Clinical/destructive testing
  • Routine end product testing
  • Decision tree
  • Processes that should be validated
  • Processes that may be fully verified
  • Processes that may need validation
  • Elements of process validation
  • Process validation protocol definition
  • Include in protocol
  • More for protocol
  • Still more for protocol
  • Installation Qualification (IQ)
  • IQ definition
  • IQ - QS requirement
  • IQ key objective
  • IQ considerations
  • More IQ considerations
  • Still more IQ considerations
  • Situation analysis - wave soldering
  • Situation analysis - package sealing
  • Operational Qualification (OQ)
  • OQ definition
  • OQ - QS requirement
  • OQ key objective
  • OQ considerations
  • More OQ considerations
  • Still more OQ considerations
  • Normal curve applied to histogram
  • Process capability
  • Situation analysis
  • Situation analysis - the question
  • Performance Qualification (PQ)
  • PQ definition
  • PQ - QS requirement
  • PQ key objective
  • PQ considerations
  • Controllable causes of variation
  • Unstable process
  • Stable process
  • Final report
  • Training operators
  • Training requirement
  • Preamble on qualified individuals
  • Documentation
  • Documenting process validation studies
  • Documenting routine production
  • Preamble on documentation
  • Maintaining a state of validation
  • Monitor and control
  • Continued state of control
  • Revalidation
  • Requirement to consider revalidation
  • Review & evaluation for revalidation
  • Reasons to consider revalidation
  • Evaluation for revalidation
  • Purchase of revalidation
  • Purchase of new equipment
  • Change component supplier
  • 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.  
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 You can buy the individual disks, or you can buy the complete training set for a 30% savings.