Tablet Process Development and Validation,

and the application of QbD

Course dates:	14 & 15 June 2010
Venue:	Window Conference Venue, Islington London UK
Cost:	£1160.00 + VAT £203.00 (Total £1363.00) A reduced rate of £1044 + £182.70 VAT  (Total £1226.70) A reduced rate if booked with "Integrated Tablet Formulation Development"
Course speaker:	Dr Michael Gamlen

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

Tablet formulation and process development staff and those involved in managing process development and validation, and commissioning products into production.  Regulatory Affairs staff preparing dossiers for tablet products.  Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols.  Numbers  will  be  limited to give  participants  the opportunity for thorough  discussion  of  the  issues  to  be covered  by  the programme  and  one  on  one consultation with speakers. 

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.

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.