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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 27, 2010 |
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PharmaTraining, Window Conference Centre, Islington, London
30 June, 2010
Course Programme
Coffee and registration will be available from 8.30am on Wednesday 30th June, course proper will commence at 9.00am. We anticipate the course will finish at 5.00pm..
Formulating and manufacturing unstable products
• Formulation development and evaluation for photolabile materials
• Protection during the manufacturing process
• Getting the product to the patient
ICH guidelines for photostability testing: Using ICH Q1B guidance in practice
• understanding the terms and procedures used in the guideline
Practicalities
• Light source selection - Options 1 and 2
• Sample presentation
• Humidity and temperature control
• Selecting sample containers
Forced degradation: Practical and regulatory aspects of photostability
stress testing
• Selecting experimental conditions for stressing samples with respect to light
Meeting regulatory requirements
• Documentation – principles and practice
• Stability testing and the Quality System
• SOPs for stability testing
• Equipment validation and calibration – do the chambers work?
• Protocol development and approval
Reporting stability test data
Delegate Workshop
Problems and issues for discussion
Additional Resources
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.
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Organized by:
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PharmaTraining |
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Invited Speakers:
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Dr Michael Gamlen, Pharmaceutical Development Services
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Deadline for Abstracts:
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N/A
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Registration:
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Register Online
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E-mail:
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judy@pharma-training-courses.com
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