Hands-on Tablet Development including principles of pre-formulation, formulation and process develop

Venue: County House

Location: Beckenham, BR3 4UF, United Kingdom

Event Date/Time: Sep 26, 2012 End Date/Time: Sep 28, 2012
Report as Spam

Description

Each day will consist of lectures on aspects
of tablet development, followed by linked sessions in which participants take part in related experimental work.
The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on
product properties, and relate the theory to the practice of Quality by Design (QbD).

Who Should Attend?
• Newcomers to tablet formulation development and manufacturing
• Production operators who need a better understanding of their products and how they have been developed
• Analytical and QC staff who would benefit from understanding the tablet development and production process
• Experienced personnel in one area of product development who need a broader overview
• Project team members needing a broader insight into formulation development including preclinical, clinical, and project management
representatives
• Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers. Regulatory
agency staff requiring practical experience

Learning outcomes
• Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
• Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and
tablet compressibility
• Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development

Venue

County House
221-241 Beckenham Road
United Kingdom
MORE INFO ON THIS VENUE

Additional Information

Course Programme Day 1 Theme - Quality by Design (QbD) - ICH Q8-10 - Material properties and their impact on processing. - The role of excipients 8.30am Registration and coffee/tea 9.00am Welcome. Introductions. Plan for the day. Learning objectives for course 9.15am Introduction to Quality by Design – a new pharmaceutical manufacturing system. Regulatory guidance. 10.45am Coffee break 11.00am Drug substance properties and their impact on formulation development. Part 1—physico-chemical properties 12.45pm Lunch 1.45pm Drug substance properties and their impact on formulation development. Part 1—physico-chemical properties 3.00pm Tea break 3.15pm Practical—impact of material properties on bulk powder behaviour • Flow • Bulk density • Compressibility • Particle size and shape 4.45pm Wrap up 5.00pm Close Day 2 Theme - Formulating good products 9.00am Consolidation. Plan for day. Learning objectives for day 9.15am Approaches to formulation development using QbD principles. Manufacturing Process selection—applicability of wet granulation/roller compaction/direct compression. Unit processes 1—blending. 10.30am Coffee break 10.45am Unit processes 2—granulation and drying. Factors affecting granulation and drying behaviour. Critical Process Parameters for these processes. Impact of powder properties on manufacturing behaviour 12.15pm Powder and granule characterisation—advanced techniques. Porosity, compressibility, surface area 12.45pm Lunch 1.30pm Granulation and drying practical 3.00pm Tea break 3.15pm Lubrication and compression practical 4.45pm Wrap up 5.00pm Close Day 3—Theme - Process development and validation 9.00am Consolidation. Plan for day. Learning objectives for day 9.15am Principles of process development. FDA Process Validation Guidance 2011 and the impact of QbD 10.30am Coffee 10.45am Identifiying Critical Process Parameters and Critical Quality Attributes • Blending • Granulation • Drying • Lubrication • Compression 12.45pm Lunch 1.45pm Practical—Direct compression products Impact of excipient selection, grades, and processing on critical quality attributes— • Compressibility • Friability • Content Uniformity • Disintegration 4.00pm Closing session with tea 10.45am Identifiying Critical Process Parameters and Critical Quality Attributes • Blending • Granulation • Drying • Lubrication • Compression 5.00pm Depart Course Speakers: Dr Michael Gamlen, Pharmaceutical Development Services - Michael is Managing Director of Pharmaceutical Development Services Ltd, a Nottingham(UK) - based technical consultancy. Dr Michael Gamlen has over 30 years experience of tablet development. 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. Dr Dipankar Dey - Dipankar joined PharmaTraining Ltd from Oystar Manesty (Liverpool) where he was Head of Process Development. He has particular expertise in manufacturing of solid dose and bio-pharmaceuticals and has worked in a number of different functions including technology transfer, new product development, training and manufacturing. He also has experience in film coating and the implementation of PAT.

Types