Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
Become a Member | Sign in
Home>Events>This Event
  Events - June 2013

Tablet Process Development, Validation and the application of QbD

12 Jun 2013 - 14 Jun 2013 - London, UK

Bookmark and Share

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.

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.

Course Programme

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


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.


Further information
Scientific News
Cell's Waste Disposal System Regulates Body Clock Proteins
New way to identify interacting proteins could identify potential drug targets.
Compound Doubles Up On Cancer Detection
Researchers have found that tagging a pair of markers found almost exclusively on a common brain cancer yields a cancer signal that is both more obvious and more specific to cancer.
Promising Drug Candidate to Treat Chronic Itch
In a new study, scientists from the Florida campus of The Scripps Research Institute (TSRI) describe a class of compounds with the potential to stop chronic itch without the adverse side effects normally associated with medicating the condition.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
Assessing Cancer Patient Survival and Drug Sensitivity
RNA editing events another way to investigate biomarkers and therapy targets.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
Inroads Against Leukaemia
Potential for halting disease in molecule isolated from sea sponges.
Molecular ‘Kiss Of Death’ Flags Pathogens For Destruction
Researchers have discovered that our bodies mark pathogen-containing vacuoles for destruction by using a molecule called ubiquitin, commonly known as the "kiss of death."
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos