Course objectives
This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed.

By the end of the course, you will understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development. Understand the relationship between material properties, formulation development and process development. Understand the processes commonly used to manufacture tablets and the factors
which affect them. Recognise how to identify critical processing parameters, and how to incorporate into a process validation program. Understand the principles of PAT, how and where it can be most effectively deployed. Know the latest FDA thinking on Process Development including the three key steps of validation.

Who should attend?
The course is designed for people new to Process Development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process better. The course will include the latest FDA guidance on the development of generic products under QbD.

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 feed forward. 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.

NOTE
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.

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 tablet development.  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.

http://pharma-training-courses.com/tablet-process-development-and-validation.html