Handling OOS Results - Live Online Training

Handling OOS Results - Live Online Training

Seminar Nr. 19425

All times mentioned are CEST.


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Dr Bernd Renger, Bernd Renger Consulting, Germany


This Live Online Training provides practical advice on how to deal with OOS Results. You will get to know the European Regulatory Expectations and what FDA and European guidelines tell us about handling OOS Results. During the training the following aspects will be covered:
  •  Repeated Testing, Retesting, reporting of results
  •  How to perform investigations on different levels
  •  Limit Excursions of critical process parameters
  •  OOL (out-of-limits) results in monitoring
  •  OOS Results of Discrete/Attribute Data
  •  OOS results in microbiological testing
  •  What makes a good OOS SOP
Participants will get OOS case studies upfront. During the training options how to deal with the results will be discussed and possible solutions will be suggested.


Since the often cited Barr ruling (Wolin Judgement) of February 1993 pharmaceutical companies all around the world have implemented procedures and strategies on how to deal with results that do not comply with their predetermined specifications. Although 27(!) years have passed since that judgement and although in the meantime FDA and MHRA have published guidances about OOSs, the investigation of OOS results continues to be a hot topic in FDA inspections. The incorrect handling and investigation of OOS results is still frequently cited in Warning Letters.

The ECA Working Group on Analytical Quality Control decided to address these aspects and developed a harmonised guideline SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. It encourages the application of  a consistent and scientifically sound approach to trend analysis as part of a QMS. The current Version 2 is available for all ECA members on the ECA members area.


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

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Regulatory Requirements for Handling OOS Results
  •  FDA and MHRA Guidelines and European Regulatory Expectations
  •  Key points and scope of the different guidelines
Handling OOS Results in the QC Laboratory – and beyond
  •  Responsibilities and how to deal with OOS results
  •  Lab scale investigation – full scale investigation
  •  Repeated testing, retesting, reporting of results
  •  Appropriate and inappropriate uses of averaging test data
Specific Cases of OOS Results
  •  OOS Results of Discrete/Attribute Data and Microbiological OOS Results
  •  OOS results in testing of attributes and dichotomic tests
  •  Limit excursions of critical process parameters
  •  OOL (out-of-limits) results in monitoring
  •  OOS results in microbiological testing
  •  OOE or OOS results in validation, calibration and SSTs
Handling OOS Results in the Microbiological Laboratory
  •  Micro OOS Results of Products
  •  OOS Results in Environmental Monitoring
Strategies not to Generate OOS Results
  •  Test procedures and specifications
  •  Meaningful SSTs
  •  Acceptance limits for the variability among replicates
  •  Sampling and averaging
  •  Deviations during testing
Workshop – OOS Results Scenarios
  •  Real OOS case studies will be presented upfront
  •  Options how to deal with the results will be discussed
  •  Possible solutions will be suggested


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