System Based Inspections - Laboratory Controls 2012

Key Topics

• Why FDA moved to Systems Based Inspections
• What is a Systems Based Inspection
• What is the Laboratory Control System
• What is different from the old inspectional techniques
• What are the responsibilities of the various units in the organization
• Has the new technique changes the findings?
• What other changes can be anticipated in FDA inspections
• What are the specific things the FDA is looking at

Who should Attend

• QA directors, managers and those involved with Change Control, deviation investigations and Training
• Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel
• Validation specialists
• Personnel in analytical development developing new methods
• Personnel involved with the testing of all dosage forms