Post-Conference OOS Workshop

Post-Conference OOS Workshop

Vienna, Austria

Course No 17302


Costs

This conference already took place. To get a list with courses and conferences in a specific subject area according to your professional demands, please visit GMP Training Courses and Conferences by topic.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr. Christopher Burgess,,  Chairman of ECA's Analytical QC Group
Dr. Bernd Renger, Bernd Renger Consulting, Germany

Programme

Directly after the OOE/ OOT Education Course the ECA OOS Workshop will be held. The following
topics will be discussed:
  • OOS: US/FDA and MHRA Guidelines and European Regulatory Expectations
  • OOS Results in R&D Laboratories
  • WORKSHOP I: ECA Analytical Quality Control Working Group - OOS SOP Version 02
  • Strategies not to generate OOS results
  • WORKSHOP II: Laboratory OOS results scenarios in QC and Development will be presented and evaluated in workshop groups

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