PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
21 & 22 November 2011
Course content:
This unique 2 day course introduces and integrates the key elements of tablet development with the
principles of Quality by Design (QbD). It will include experimental, hands-on experience of formulation
development using the Gamlen Tablet Press. Topics include:
Day 1 The Product Development Lifecycle
• Making sense of ICH Q8, 9 and 10—moving from theory to practice
• Designing formulations and processes to meet the Target Product Profile
Formulation development
• Formula selection
• Process selection
• Product Optimisation and the formulation cycle
• Developing Product Control Strategies at the formulation development phase
• Coating polymers
Day 2 Advance characterisation and development techniques
• Formulation mapping using X-ray and Raman spectroscopy
• AFM in formulation development
• Real time particle size analysis
• Dryer control using NIR
• Blend uniformity assessment using NIR and other techniques
• Compressibility comparison using the Gamlen Tablet Press
• Characterisation of tablet coats using THz spectroscopy
Proper integration of all of these elements is essential to achieve “Quality by Design” because data from
each phase is used to control the next step in the development process. By achieving proper integration
based on sound scientific principles, many development and production problems can be avoided. The
course includes case studies of tablet formulation development and a detailed step by step analysis of all
elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific
learning in this participative course.
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Invited Speakers:
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Dr Michael Gamlen, Pharmaceutical Development Services
Michael is Managing Director of Pharmaceutical Development Services Ltd, a Guildford (UK) -based
technical consultancy. He has over 35 years experience of tablet development. 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 has since worked for Vanguard Medica Ltd and as a consultant. He 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 case.
Michael continually updates the content of his courses with the latest guidance and extracts of up-to-the
minute scientific papers.
Dr Dipankar Dey, PharmaTraining Ltd
Dipankar Dey recently joined PharmaTraining Ltd as Training Manager. A graduate of Oxford University
and with a PhD from Birmingham University, he was until recently Head of Process and Validation at
OYSTAR Manesty, a well known tablet equipment manufacturer. Dipankar has experience in both sterile
and solid dose pharmaceuticals, particularly in tablet coating and compression and is interested in PAT
techniques to extract useful online information.
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Registration:
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Tablet Formulation Development, 21 & 22 November 2011, London
2 day course £1062.00 (+ VAT £232.40 if applicable see VAT NOTES) Total £1294.40
if booked and paid eight weeks prior to course commencement
Full fee: 2 day course £1180.00 (+ VAT £236.00 if applicable see VAT NOTES) Total £1416.00
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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