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 01
Overview –The FDA Quality System Regulations
Video Length:
ID# DTA101
Price:
$145.00

Disk 1 of 10  (50 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

  • Purpose of this module
  • Introduction
  • Why comply?
  • Evolution of quality - no quality
  • Quality control
  • Quality assurance & GMP
  • Quality system
  • Quality management system
  • QS history - GMP
  • QS history - recall study
  • QS history - SMDA
  • QS history - proposed Revision 1
  • QS history - proposed Revision 2
  • QS history - working draft
  • QS history - controversial issues
  • QS history - final rule
  • QS history - design controls
  • QS & GHTF - general
  • QS & GHTF’s - influence
  • QS & ISO standards
  • ISO 9001:2003
  • ISO 13485:2003
  • Definition - quality system
  • QS flexible regulation
  • Seven subsystems diagram
  • Management control purpose
  • Policy, procedures, management rep
  • Training, resources, reviews, audits
  • Design control purpose
  • Procedures, plan, interfaces
  • Input, output, verification
  • Transfer, validation, reviews
  • Changes, documentation
  • Production & process control purpose
  • Process & software validation
  • Control, monitor, acceptance, sampling
  • Corrective & preventive action purpose
  • Seven subsystem diagram
  • Analyze, investigate, CAPA
  • Verify/validate CAPAs, communicate
  • Documents, records changes Purpose I
  • Documents, records changes Purpose II
  • Documents & change control
  • Material control purpose
  • Purchasing, acceptance, sampling
  • Traceability, handling, storage, distribution
  • Facility & equipment control purpose
  • Install, maintenance, calibration
  • Diagram of seven subsystems
  • 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.