Tablet Process Development, Validation and the application of QbD
12 Jun 2013 - 14 Jun 2013 - London, UK
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
Morning - Product
- Principles of Quality
by Design and the product development process
- Linking material
properties to formulation and processing behaviour
- FDA Guidance on Process
- 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
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 endpoint
Afternoon - Drying,
compression and film coating
- Drying - techniques and
- Compression -
opportunities and threats!
- Developing film coating
- Round-up session
Day 3: Practical
- Granule and product
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.