Tablet Process Development and Validation and the application of QbD (3 day)

Day 1:  
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 powder
mixing behaviour  

Day 2:  
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  
• Blending  
• Granulation  
• Drying  
• Milling  
• Sieving  
• Compression  
• Granule and product characterisation  
 
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. Numbers are restricted to guarantee personal involvement.

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%