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 03
Documents, Records, and Change Control; Identification and Traceability
Video Length:
ID# DTA103
Price:
$145.00

Disk 3 of 10  (51 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
  • Subsystem purpose
  • Document control requirements
  • Procedures
  • Approval and distribution
  • Document changes
  • Review and approval
  • Approval date and signature
  • Availability
  • Change review
  • Who reviews changes?
  • Change record
  • Description of changes
  • Affected documents
  • Approval signatures
  • Approval date
  • Effective date of change
  • Situation analysis - change
  • Changes and other documents
  • Situation analysis - date of change
  • Records:  general requirements
  • requirements
  • Situation analysis - availability
  • Legible records
  • Record storage
  • Confidentiality
  • Record retention
  • Situation analysis - keeping records
  • Availability - exceptions
  • Exceptions - management reviews
  • Exceptions - quality audits
  • Exceptions - purchasing evaluations
  • Exceptions - procedures
  • Records 820.40 & 820.180
  • Device Master Record (DMR)
  • Definition DMR
  • DMR requirements
  • DMR content
  • DMR specifications
  • Specification examples
  • DMR processes
  • Process examples
  • DMR quality assurance
  • QA examples
  • DMR packaging, labeling
  • Packaging, labeling examples
  • Install, maintain, service
  • Examples
  • DMR Miscellaneous
  • Device History Record (DHR)
  • Definition - DHR
  • DHR requirements
  • DHR content
  • DHR date of manufacture
  • DHR quantity manufactured
  • DHR quantity released
  • Acceptance records
  • Quality System Records (QSR)
  • Definition - QSR
  • QSR requirements
  • Identification & traceability
  • Identification requirements
  • Traceability scope
  • Traceability requirements
  • Definition - lot or batch
  • 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.