Corporate Banner
Satellite Banner
Biologics & Bioprocessing
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
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Long-Term Culturing of Adult Stem Cells
A new procedure developed by Harvard Stem Cell Institute researchers (HSCI) at Massachusetts General Hospital (MGH) may revolutionize the culturing of adult stem cells.
Solutions for Biotherapeutic Characterization
Innovation to speed the routine.
Plant-Based Vaccine Among Front Runners In Search For New Polio Jab
A researcher from Norwich is part of a consortium that has been awarded $1.5 million to develop safer polio vaccines, using a new technique developed at the John Innes Centre.
Harnessing Helpful Microbes
Seeking to further harness microbes’ many uses, the federal government has launched the National Microbiome Initiative (NMI) to “foster the integrated study of microbiomes across different ecosystems.”
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
A New Approach to Chemical Synthesis
Communesins, originally found in fungus, could hold potential as cancer drugs.
Better Animal Model to Improve HIV Vaccine Development
Penn study identifies a new tool to produce better HIV vaccine designs.
First Large-Scale Proteogenomic Study of Breast Cancer
The study offers understanding of potential therapeutic targets.
Developing a More Precise Seasonal Flu Vaccine
During the 2014-15 flu season, the poor match between the virus used to make the world’s vaccine stocks and the circulating seasonal virus yielded a vaccine that was less than 20 percent effective.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!