Tablet Process Development and Validation and the application of QbD (3 day)
Venue: Window Conference Venue
|Event Date/Time: Jul 09, 2012||End Date/Time: Jul 11, 2012|
|Early Registration Date: May 14, 2012|
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.
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 pow-der mixing behaviour
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, at County House, Beckenham. Transport provided.
. Granule and product characterisation
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. Numbers are restricted to guarantee personal involvement.
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.
Michael continually updates the content of his courses with the latest guidance and extracts of up-to-the minute scientific papers. He provides a substantial body of relevant literature to all course participants as well as copies of all notes and guidance used and a workbook. He is a popular and highly respected presenter.
Dr Dipankar Dey - Dipankar joined PharmaTraining Ltd from Oystar Manesty (Liverpool) where he was Head of Process Development. He has particular expertise in manufacturing of solid dose and bio-pharmaceuticals and has worked in a number of different functions including technology transfer, new product development, training and manufacturing. He also has experience in film coating and the implementation of PAT.