Tablet Process Development and Validation and the application of QbD (3 day)
11 Dec 2012 - 13 Dec 2012 - County House, 221-241 Beckenham Road, Beckenham, BR3 4UF, Nr London
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. The hands-on workshop day will enable you to
experience at first hand the impact of processing parameters on product
By the end of the course,
Understand the relationship between the principles of QbD and
tablet development and process validation in generic and new product
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
Know the latest FDA thinking on Process Development including the
three key steps of validation
Gain practical hands on experience of the impact of processing
parameters on product quality on the small scale.
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
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
Morning - EFPIA Case study. Wet granulation
• The new regulatory landscape. Q8, Q9 and Q10 and their impact on product and
• 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
Drying, compression and film coating
• Drying - techniques and process control
• Compression - opportunities and threats!
• Developing film coating processes
• Round-up session
Day 3: Practical
• 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.
Ful Course Speakers
Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd,
a pharmaceutical consultancy based in Nottingham (UK).
Dr Dipankar Dey, PharmaTraining Ltd - Dipankar Dey
recently joined PharmaTraining Ltd as Training Manager.
Full Fee: 3 day course £1770.00 (+ VAT £354.00 if applicable, see notes on VAT)
Discount of 10% applies for booking 8
weeks in advance. Discount of 10% applies for booking more than 1 delegate.
Discount of 10% applies for booking more than 1 course.
Maximum discount received is 15%