Tablet Process Development, Validation and the Application of QbD

Overview

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.

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 Programme

Day 1

Morning - Product development

• Principles of Quality by Design and the product development process
• Linking material properties to formulation and processing behaviour
• FDA Guidance on Process Validation
• Workshop session - Understanding Quality by Design

Afternoon - Mixing, and dry granulation

• Identifying potential Critical Process Parameters.
• 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 - EFPIA Case study. Wet granulation

• The new regulatory landscape. Q8, Q9 and Q10 and their impact on product and process development.
• EFPIA case study - what would a QbD regulatory submission look like
• Use of Process Matrices in process development
• Developing wet granulation processes
• Granulation endpoint control

Afternoon - Drying, compression and film coating

• Drying - techniques and process control
• Compression - opportunities and threats!
• Developing film coating processes
• Round-up session

Day 3: Practical

• Blending
• Granulation
• Drying
• Milling
• Sieving
• Compression
• Granule and product characterisation

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.