Developing Pharmaceutical Tablets for Low Cost Manufacturing
Day 1
Product development
- The Product Development Lifecycle.
- Making sense of ICH Q8, 9 and 10″moving from theory to practiceDesigning formulations and processes to meet the Target Product Profile
- Key pharmaceutical process
Blending
Granulation
Drying
Compression
Film coating
- Product Optimisation and the formulation cycle.
- Compressibility assessment using the Gamlen Tablet Press
- Problems for particular products
Effervescent
Film coated
Extended release
Day 2
Process development
- Developing robust processes which work every time
- Selecting and evaluating Design Space
- DOE”how can statistics help. Approaches to experimental design
- Developing Product Control Strategies for effective cost control
- Process Analytical Technology”strengths and weaknesses
- Key techniques for Statistical Process Control and how they can be used to control costs
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 formulation experience.
Michael Gamlen (Tableting and Stability Testing Expert)
Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
The course is designed for
- People new to tablet development or requiring a refresher in the area
- Process Development experts wishing to extend their understanding
- Production supervisors and managers
- Quality control and regulatory staff who need to understand how products are made and where costs arise.
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