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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.

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 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.