Change Management – Changes and Deviations

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 GMP-Regulations and GMP-Requirements for Change Control
  • Europe
  • FDA
  • Harmonised requirements
09.30 - 10.30 Definition and Differences
  • Changes
  • Deviations
  • Change management
10.30 -10.45 Break
10.45 - 11.45 Changes and Deviations in Production
  • Implication on the processes
  • Implication on the quality of the product
  • Assessment of the changes/deviations
11.45 - 12.45 Changes and Deviations in Quality Control
  • Implication on the processes
  • Implication on the quality of the product
  • Assessment of the changes/deviations
  • OOS as a deviation
12.45 - 13.45 Lunch
13.45 - 14.45 Changes and Deviations in other Departments
  • Quality assurance
  • Engineering
  • IT
  • Purchases etc.
14.45 - 15.00 Break
15.00 - 16.00 Building up of a Management System
  • Building up of an overall System
  • Incorporation of the management
  • Incorporation of external
  • SOP
16.00 - 17.00 Assessment of the Changes in Respect to Registration
  • Requirements of the EC
  • Requirements of the FDA
17.00 - 17.30 Discussion

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