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FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 04
Design Control
Video Length:
ID# DTA104
Price:
$145.00

Disk 4 of 10  (1 hour 9 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
  • Purpose of the design control subsystem
  • Design control - scope
  • Design control - scope § 820.30(a)
  • Design control - general § 820.30(a)
  • Design planning
  • Design & development planning - § 820.30(b)
  • When to implement design controls?
  • What should be in the plan?
  • Design input
  • Definition - § 820.3(f)
  • Design input - § 820.30(c)
  • Sources of design input
  • Types of design input
  • Design inputs
  • What are some examples of design input?
  • Situation analysis
  • Situation analysis:  hospital vs. home use
  • Design output
  • Definition - § 820.3(g)
  • Design output - § 820.30(d)
  • In other words…
  • Documenting design output § 820.30(d)
  • Design review
  • Definition - § 820.3(h)
  • Design review - § 820.30(e)
  • Design review - preamble
  • More on design review
  • Situation analysis
  • Design verification
  • Definition - § 820.3(aa)
  • “Objective evidence”
  • Design verification vs. design validation
  • Design verification - § 820.30(f)
  • Design validation
  • Definition - § 820.3(z)
  • Design validation vs. process validation
  • Design validation - § 820.30(g)
  • I can use “equivalent devices?”
  • Risk analysis?
  • Design transfer
  • Design transfer § 820.30(h)
  • Design changes
  • Design changes - § 820.30(i)
  • Minimum design control requirements for manufacturers
  • Every change?
  • How much is enough?
  • when making changes, remember….
  • Design history file
  • Definition - § 820.3(e)
  • Design history file § 820.30(j)
  • Design history file
  • Situation analysis
  • Device labels and labeling
  • Device labeling - § 820.120(a)
  • Label content and the FD&C Act
  • Situation analysis
  • Device packaging
  • Device packaging - § 820.130
  • 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.