All times mentioned are CEST.
Zielsetzung
- 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
Hintergrund
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.
Zielgruppe
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.
Programm
Gesamtes Programm als PDF herunterladen
- FDA and MHRA Guidelines and European Regulatory Expectations
- Key points and scope of the different guidelines
- 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
- 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
- Micro OOS Results of Products
- OOS Results in Environmental Monitoring
- Test procedures and specifications
- Meaningful SSTs
- Acceptance limits for the variability among replicates
- Sampling and averaging
- Deviations during testing
- 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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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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