09.00 – 09.15 h
Introduction
09.15 – 10.15 h
Handling OOS Results in the QC Laboratory
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
10.15 – 10.30 h
Questions & Answers
10.30 – 10.45 h Break
10.45 – 11.45 h
Specific Cases of OOS Results
Including 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
11.45 – 12.00 h
Questions & Answers
12.00 – 13.00 h Break
13.00 – 13.45 h
ECA Analytical Quality Control Working Group OOS SOP
- ECA’s Analytical Quality Control Group
- Scope and application of the SOP
- Extended flow chart
- Identification, isolation & evaluation of OOS results
- How many retests?
13.45 – 14.00 h
Questions & Answers
14.00 – 15.00 h
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
15.00 – 15.15 h
Questions & Answers
15.15 – 15.30 h Break
15.30 – 16.30 h
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
16.30 – 16.45 h
Overall Questions & Answers Session
16.45 h End of Training