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.

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.

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

Dress casual, you may get wet or dusty.