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 06
Production and Process Control; Facility and Equipment Control
Video Length:
ID# DTA106
Price:
$145.00

Disk 6 of 10  (1 hour, 11 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
  • Subsystem purposes
  • Overview
  • Production and process control - § 820.70
  • Process controls - production processes
  • Process controls help assure conformance
  • SOPs, monitoring & control
  • Reference standards & approvals
  • Criteria for workmanship
  • Control and monitoring:  packaging for sterile devices
  • Production and process changes
  • Situation analysis
  • Environmental control
  • Preamble on environmental control
  • Inspecting environmental controls
  • Cleanroom classification & monitoring
  • Production labeling calibration
  • Cleanroom design and biocontamination control
  • Evaluation of cleanroom biocontamination data
  • Personnel
  • Preamble on personnel
  • Situation analysis
  • People and cleanrooms
  • Clothing for the controlled environment
  • Situation analysis
  • Contamination control
  • Preamble on contamination control
  • Buildings
  • Equipment
  • Situation analysis
  • Equipment maintenance schedule
  • Documenting equipment maintenance
  • Equipment inspection
  • Documenting equipment inspection
  • Equipment adjustment
  • Manufacturing material
  • Definition of manufacturing material
  • Preamble on manufacturing material
  • Use and removal of manufacturing material
  • Document use of manufacturing materials
  • Document removal/reduction of manufacturing material
  • Automated processes
  • Preamble on software validation
  • Preamble on software
  • CDRH software validation guidance
  • Software changes
  • Device Labeling - § 820.120
  • Device Labeling - general
  • Preamble on labeling control
  • Labeling inspection
  • Preamble on labeling inspections
  • Documenting labeling inspection
  • Labeling storage
  • Labeling operations
  • Labeling documentation
  • Inspection, measuring, and test equipment - § 820.72
  • Controlling inspection, measuring & test equipment
  • Maintaining accuracy and fitness for use
  • Situation analysis
  • Calibration procedures
  • Situation analysis
  • Calibration standards
  • Calibration 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.