Corporate Banner
Satellite Banner
ADME Tox
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
RNAi Screening Trends
Understand current trends and learn which application areas are expected to gain in popularity over the next few years.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
Long-sought Discovery Fills in Missing Details of Cell 'Switchboard'
A biomedical breakthrough reveals never-before-seen details of the human body’s cellular switchboard that regulates sensory and hormonal responses.
Tracking Breast Cancer Before it Grows
A team of scientists led by University of Saskatchewan researcher Saroj Kumar is using cutting-edge Canadian Light Source techniques to screen and treat breast cancer at its earliest changes.
Zebrafish Reveal Drugs that may Improve Bone Marrow Transplant
Compounds boost stem cell engraftment; could allow more matches for patients with cancer and blood diseases.
Teeth Reveal Lifetime Exposures to Metals, Toxins
Researchers have identified dental biomarkers to reveal links between early iron exposure and late life brain diseases.
An Innovative Algorithm to Decipher How Drugs Work Inside the Body
Researchers at Columbia University Medical Center (CUMC) have developed a computer algorithm that is helping scientists see how drugs produce pharmacological effects inside the body.
Uncovering the Spread of Bacteria in Pneumonia
Northwestern Medicine scientists have discovered the role a toxin produced by a pneumonia-causing bacterium plays in the spread of infection from the lungs to the bloodstream in hospitalized patients.
Ferring Bets on Bacteriophages to Treat Inflammatory Bowel Disease
Ferring Pharmaceuticals have annoucned that it will collaborate with Intralytix in the latest phase of its early stage development programme for a bacteriophage-based therapy for inflammatory bowel disease (IBD).
Rare Form: Novel Structures Built from DNA Emerge
DNA, the molecular foundation of life, has new tricks up its sleeve. The four bases from which it is composed can be artificially manipulated to construct endlessly varied forms in two and three dimensions.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!