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KI

FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 05
Material Control
Video Length:
ID# DTA105
Price:
$145.00

Disk 5 of 10  (59 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

  • Seven subsystems
  • Material control subsystem
  • Overview
  • Definitions - § 820.3
  • Definition:  product
  • Definition:  component
  • Definition:  manufacturing material
  • Definition:  finished device
  • The preamble on manufacturing material
  • Definition:  nonconformity
  • The preamble on nonconformity
  • Purchasing controls § 820.50
  • Purchasing controls
  • Procedures for purchasing controls
  • The preamble on purchasing control requirements
  • Situation analysis
  • Purchasing controls
  • Evaluation and selection
  • Situation analysis
  • The preamble on supplier evaluations
  • The preamble on degree of supplier control
  • Control
  • The preamble on control over products and services
  • Records
  • Purchasing data
  • Statistical techniques § 820.250
  • Acceptance activities § 820.80
  • Receiving acceptance activities
  • The preamble on control over products and services
  • Situation analysis
  • In-process acceptance activities
  • Situation analysis
  • Preamble on in-process testing
  • Final acceptance activities
  • Final acceptance activities - release for distribution
  • Acceptance records
  • Acceptance status
  • Handling - § 820.140
  • Handling procedures
  • Storage - § 820.150
  • Storage procedures
  • Products that deteriorate
  • Receipt & dispatch
  • Distribution § 820.160
  • Distribution procedures
  • Distribution
  • Distribution records
  • Installation § 820.170
  • Installation instructions
  • Availability of instructions
  • Situation analysis
  • Installation - installer responsibilities
  • Preamble on installer responsibilities
  • Preamble on installer records
  • 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.