Quality by Design Workshop

REGISTRATION NOW OPEN

17 and 18 October 2019
The Venue@DMU, Leicester

The Leicester School of Pharmacy and ISPE UK Affiliate are providing a 2-day workshop on the practical application of Quality by Design (QbD) including hands-on practical work and classroom training sessions.

Working on process elements of Oral Solids Dosage Formulations the workshop will provide delegates with a grounding in ICH quality guidelines and an understanding of Design of Experiments (DoE) as well as the relationship between Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) of products.

The workshop will explore the impact of CQA of materials on final products. 

The 2-day workshop will intersperse classroom sessions and practical work covering:

Lectures

  • Developments in manufacturing of Pharmaceutical Products
  • Overview of ICH Q8 principles
  • Risk Assessment
  • DoE, QbD and control parameters
  • Multivariate data analysis
  • Regulatory framework for use of QbD in Manufacturing

Practical

  • Sample preparation with MeltPrep VCM Technology and in-situ UV-Vis analysis
  • Milling with Quadro SLS Comil
  • Particle Size Analysis
  • Compaction properties for tabletting

The workshop, whilst using OSD Formulation, will provide principles that can be applied across the range of pharmaceutical manufacturing processes.

Registration includes two day workshop with lunches and networking dinner on the first evening.

Details of local hotels can be provided

Registration
ISPE Membership No
Associated Organisation

Associated organisation members include PHSS, IChemE and IMechE