- GMP and Compliance
- Pharmaceutical Product Development
- Developing Pharmaceutical Tablets for Low Cost Manufacturing
- Development and Manufacture of Effervescent Tablets
- Discussion Group - QbD and Lifecycle Management for Analytical Methods
- HPLC Analytical Method Development and Validation
- Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev
- Introduction to Photostability
- Pharmaceutical Packaging - an introductory course
- Pharmacokinetics in Drug Development - an integrated approach
- Preformulation Studies for Tablet Development
- QbD and Lifecycle Management for Analytical Methods
- Stability Testing in Pharmaceutical Development and Manufacture
- Tablet Formulation Development
- Tablet Formulation Development - Formulation development in practice
- Tablet Process Development, Validation and the Application of QbD
- Technology Transfer
- Pharmaceutical Manufacturing Support
- Pharmaceutical R&D Support
- In-house Training Courses
Tablet Process Development, Validation and the Application of QbD
|Tutor : Michael Gamlen and Dipankar Dey|
|12 - 14 June 2013||Beckenham||£1,770 + Vat|
OverviewThis 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 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 powder 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
- 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.
Dress casual, you may get wet or dusty.