Deviation, Failure Investigation, Annual Product Review and Change Management

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 Regulatory Requirements
  • Europe
  • USA
09.30 - 10.30 Out of Specification, OOS
  • The Barr Case
  • OOS Failures
  • Treatment of OOS
10.30 -10.45 Break
10.45 - 11.45 Deviation and Changes
  • Differences between deviations and changes
  • Occurrence of deviations and changes
  • Treatment of deviations and changes
11.45 - 12.45 Root Cause Analysis
  • Treatment and carry out
  • Involvement of other departments
12.45 - 13.45 Lunch
13.45 - 14.45 Assessment of Deviation and Changes
  • Risk analysis
  • Outcome of the assessment
  • Relation to other products
14.45 - 15.00 Break
15.00 - 16.00 Trending/Annual Product Review
  • Assessment and trending of changes and deviations
  • Preparing for a report
  • Content of the report
16.00 - 17.00 Change Management System
  • Quality management system
  • SOPs
  • Involvement of contract manufacturer
17.00 - 17.30 Discussion

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