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Tablet Process Development and Validation and the application of QbD

  February 20, 2011  
Pharma Training, Window Conference Venue, London UK
13 & 14 June 2011

Course outline


Day 1: Morning—Product development

  • The new regulatory landscape. Q8, Q9 and Q10 and their impact on product and process development
  • Principles of Quality by Design and the product development process
  • Linking material properties to formulation and processing behaviour
  • Workshop session—Understanding Quality by Design

Afternoon—Mixing and blending

  • Identifying potential Critical Process Parameters.
  • Use of Process Matrices in process development.
  • Unit processes 1—Mixing and blending
  • Assessing blend uniformity. Sampling problems and practice
  • Workshop session—blend assessment practical. Effect of material properties on powder mixing behaviour

Day 2: Morning—Granulation—wet and dry

  • Why granulation matters—good and bad
  • Critical granulation process parameters and their impact
  • Optimising granulation processes
  • Workshop session—granulation practical. Effect of binder volume on product properties

Afternoon—Process Control and Process Analytical Technology (PAT)

  • Principles of process control—feedback and feedforward
  • Use of advanced techniques—limitations and applicability
  • Case studies—what has been done? What is possible?
  • Continuous processing
  • Participants open forum and Question and Answer session.



Wherever possible participants should bring practical problems and
examples which can be reviewed on the course. The course will be highly participative and useful for people with or without experience.

Dress casual, you may get wet or dusty.
Organized by: Pharma Training
Invited Speakers:

Dr Michael Gamlen, Pharmaceutical Development Services


Deadline for Abstracts: n/a
Registration: Register on the website or by e-mail
E-mail: judy@pharma-training-courses.com
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