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PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
23 - 24 October 2012
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
• Introduction and definition of OOT/OOS Out of Trend Results
• Defining the main categories of OOS results
• Review of FDA’s guidelines (Oct 2006)
• Examples and case studies of regulatory observations
10.30 Morning refreshments
Morning Session 2 - 10.45 am to 12.30pm
• Quality documentation required to support OOS investigations
• Responsibilities
• Investigating OOS results - Phase 1
° Flow chart
° Checklist
12.30 Lunch
Afternoon Session 1 - 13.30 to 15.15pm
• Investigating 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
Phase 1 Case studies
These are interactive group exercises where the participants utilise their experience and new learnings 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
• Case studies Phase 2
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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Organized by:
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PharmaTraining Ltd |
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Invited Speakers:
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Course Speaker
Dr Pauline McGregor
Twenty years in the pharmaceutical industry has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK.
Pauline completed her honours degree in Scotland on a part time basis while employed full time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students.
On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering analytical R& D, method validation, GMP and related Quality Systems courses across Canada, in the US, the UK and China . She is a very highly rated presenter.
Throughout her career, Pauline has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding.
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Deadline for Abstracts:
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Registration:
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Full Fee: 2 day course £1180.00 (+ VAT if applicable, see VAT NOTES)
Discounted rate for registering and paying before 17 August 2011 - 2 day course £1062.00 (+ VAT if applicable, see VAT NOTES)
Discount of 10% applies for booking 8 weeks in advance
Discount of 10% applies for booking more than 1 delegate
Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%
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E-mail:
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judy@pharma-training-courses.com
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