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 02
Scope and Management Control
Video Length:
ID# DTA102
Price:
$145.00

Disk 2 of 10  (1 hour, 2 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
  • Scope
  • Definition - manufacturer
  • Definition - finished device
  • Situation - device manufacturer?
  • Components and accessories
  • Packaged, labeled for distribution
  • Situation - scope
  • Definition - Remanufacturer
  • Situation - Remanufacturer I
  • Situation - Remanufacturer II
  • Exemptions from QS regulations
  • Definition - establish
  • Meaning of “where appropriate”
  • Justifications
  • Justification considerations
  • Inspection foreign manufacturers
  • Management controls purpose
  • Management responsibility
  • Definition - quality system
  • Quality systems requirements
  • Definition - quality policy
  • Quality policy requirements
  • Situation - quality policy
  • Organization requirements
  • Responsibility & authority
  • Situation - inspecting assemblies
  • Resources requirements
  • Resources - assignment
  • Management with executive responsibilities
  • Management representative
  • Responsibilities
  • Situation - management rep
  • Management review
  • Management review requirements
  • Situation - management review 
  • Management review requirements
  • Management review certification
  • Quality planning requirements
  • ISO guidelines for quality plans
  • Quality system procedures
  • Quality audits
  • Definition - quality audit
  • Procedures & purpose
  • Auditors, corrective actions
  • Management review of quality audits
  • Documentation of quality audits
  • FDA & audit reports vs. procedures
  • Quality planning
  • Quality management - guidelines for quality plans
  • Quality system procedures
  • Quality audit § 820.3(t) and § 820.22
  • Quality audit:  definition
  • Quality audit procedures & purpose
  • Quality audit - auditors
  • Quality audit reports
  • Quality audit documentation
  • quality audit certification
  • Personnel § 820.25
  • Training
  • Training on defects and errors
  • 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.