Corporate Banner
Satellite Banner
RNAi
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

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.

Dress casual, you may get wet or dusty.

 



Further information
Scientific News
Advancing Synthetic Biology
Living systems rely on a dizzying variety of chemical reactions essential to development and survival. Most of these involve a specialized class of protein molecules — the enzymes.
NIH Researchers Identify Striking Genomic Signature for Cancer
Institute has identified striking signature shared by five types of cancer.
CRI Develops Innovative Approach for Identifying Lung Cancer
Institute has developed innovative approach for identifying processes that fuel tumor growth in lung cancer patients.
Counting Cancer-busting Oxygen Molecules
Researchers from the Centre for Nanoscale BioPhotonics (CNBP), an Australian Research Centre of Excellence, have shown that nanoparticles used in combination with X-rays, are a viable method for killing cancer cells deep within the living body.
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
"Gene Fusion" Drives Childhood Brain Cancers
Study co-led by Penn scientists highlights potential targets for future cancer therapies.
Scroll Up
Scroll Down
SELECTBIO

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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!