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Hands-on Tablet Development including principles of pre-formulation, Formulation and process development (3 day)

 
  December 15, 2011  
     
 
PharmaTraining Limited, County House, 221-241 Beckenham Road, Beckenham, BR3 4UF
27 - 29 March 2012


Day 1

Theme

  • Quality by Design (QbD) - ICH Q8-10
  • Material properties and their impact on processing
  • The role of excipients Course Programme

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

5.00pm Depart

 
 
Organized by: PharmaTraining Ltd
Invited Speakers:

This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. 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).

Dr Michael Gamlen, Pharmaceutical Development Services

Dr Dipankar Dey, PharmaTraining Ltd

 
Deadline for Abstracts: .
 
Registration: www.pharma-training-courses.com
E-mail: judy@pharma-training-courses.com
 
   
 
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