PharmaTraining, Window Conference Centre, Islington, London
21 & 22 June, 2010
Course outline
Questions and answers will be taken throughout the duration of
the course.
Day 1
8.30 Registration and Coffee Morning Session 1
9.00 to 10.30am - Definition and categories of OOS Results
- Review of FDA’s guidelines (Oct 2006)
- Examples and case studies of regulatory observations
- Quality documentation required to support OOS investigations
10.30 Morning refreshments Morning Session 2
10.45 am to 12.30pm - Responsibilities
- Defining the main categories of OOS results
- Investigating OOS results - Phase 1
12.30 Lunch
Afternoon Session 1
13.30 to 15.15pm - Investigating and OOS result Phase 1 (continued)
- Determining the root cause
- Common Laboratory errors
- Regulations and industry response to invalidating OOS results
15.15 Afternoon refreshments
Afternoon Session 2
15.30 to 17.30pm These are interactive group exercises where the participants utilise their experience and new learning’s to figure out more appropriate action than that which was taken as described in the examples. Their answers are then compared to the actual FDA response. Group discussions follow.
17.30pm End of day
Day 2 Morning Session 1
9.00 to 10.30am - Investigating OOS results Phase 2
- Flow chart
- Checklist
- Examples of root causes found during Phase 2 investigations
10.30 Morning refreshments Morning Session 2
10.45 am to 12.30pm 12.30 Lunch
Afternoon Session 1
13.30 to 15.15pm - Additional Laboratory Testing (Retesting and Resampling)
- Reporting Test Results
- Concluding the Investigation and Evaluating the results
15.15 Afternoon refreshments
Afternoon Session 2
15.30 to 17.00pm - Corrective and Preventative Actions
- The Audit Trail
- Minimising future OOS results
17.00pm End of day
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