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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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September 04, 2012 |
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PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
23 November 2012
Coffee and registration will be available from 8.30am, 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 Ltd |
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Invited Speakers:
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Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd, a pharmaceutical consultancy based in Nottingham (UK). Dr Gamlen has over 30 years experience of product stability testing. Awarded a First Class Honours degree in Pharmacy, specialising in Pharmaceutical Engineering, he studied for a PhD at Nottingham University. He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and worked as an outsourcing manager before starting his consultancy business in 2000.
Dr Gamlen specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years and his courses are highly rated, exceeding the expectation of the participants in many cases. Michael continually updates the content of his courses with the latest guidance and extracts of up-to-the minute scientific papers. He provides a substantial body of relevant literature to all course participants as well as copies of all notes and guidance used and a workbook. He is a popular and highly respected presenter
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Deadline for Abstracts:
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Registration:
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Early-bird Fee:
1 day course £549.00 (+ VAT £109.80 if applicable, see VAT NOTES)
Discounted rate for registering and paying before 28 September 2012
Full Fee: 2 day course £610.00 (+ VAT £122 if applicable, see VAT NOTES)
Reduced rate of 10% if also booking Stability Testing in Pharmaceutical
Development and Manufacture
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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