Post-Conference OOS Workshop

Post-Conference OOS Workshop

Berlin, Germany

Course No 18322

 

Costs

ECA-Member: EUR 790,--
Non ECA Member: EUR 890,--
EU/GMP Inspectorates: EUR 445,--
APIC Member Discount: EUR 840,--

(All prices excl. VAT)

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,Burgess Analytical Consultancy, UK
Dr Bernd Renger, Bernd Renger Consulting, Germany

Objectives

In the ECA OOS Workshop the following topics will be discussed:
  •  OOS: US/FDA Guidelines and European Regulatory Expectations
  •  OOS Results in R&D Laboratories
  •  Strategies not to generate OOS results
The current version of the OOE/OOT Laboratory Data Management Guidance will be presented and participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document as well as looking at the scope and application of the proposed methods within industry.

Target Group

This training is recommended for all levels of technical staff and managerial personnel dealing with out-of-trend results and out-of-specification results, including analytical laboratories, contract laboratories, and Quality Assurance/Quality Control personnel.

Programme

Directly after the OOE/OOT Education Course the ECA OOS Workshop will take place.

The following topics will be discussed:
  •  OOS: US/FDA and European Regulatory Expectations
  •  OOS Results in R&D Laboratories – Specific Cases of OOS Results
  •  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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