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:
Keynote Speaker:
- Prof Kendal Pitt - Senior Technical Director, OSD, GSK
Industry Speakers:
- Dr Phil Borman - Senior Fellow and Director, Product Quality, GSK
- Dr David Elder - Principal Consultant, David P Elder Consultancy
- Prof Gordon Muirhead - President, GMPharma
- Dr Daniel Treffer - Founder and CEO, Meltprep
- Sana Ahmed - Application Specialist, QbD Vision
- Dr Bruno Leclercq - Pharmacist/Business Development Manager, MedelPharm
Academic Lead:
- Dr Walkiria Schlindwein, DMU, Leicester School of Pharmacy
Day 1
- QbD applied to tabletting: real world examples - Prof Kendal Pitt
- Regulatory Landscape for QbD - Dr Phil Borman
- The criticality of risk assessment in life cycle management (Case Study) - Dr David Elder
- QbD applied to continuous extrusion processes using in line spectroscopy - Dr Walkiria Schlindwein
- Practical Sessions:Evaluating the effect of CPPs and material attributes on product CQAs
- Sample preparation with MeltPrep VCM Technology and ColVisTec in-situ UV-Vis analysis
- Milling with Quadro SLS Milling Technology
- Particle Size Analysis by Retsch
- Compaction properties for tabletting with MedelPharm Styl'One
- Data analysis, sources of variability and control strategy
Day 2
- Applying QbD tools to pharmaceutical continuous manufacture - Prof Gordon Muirhead
- Manufacturing Classification System - a proposal for OSD forms - Prof Kendal Pitt
- Rapid Lossless prototyping of hot melt extruded formulations with in-line PAT tools - Dr Daniel Treffer
- Mimicking Industrial Rotary Tablet Presses - Dr Bruno Leclercq
- Practical Sessions: Developing control strategies and continuous improvement
- Spatial Analytics using QbD Vision- linking criticality through development and manufacturing processes - Sana Ahmed and Dr Walkiria Schlindwein
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
Associated organisation members include PHSS, IChemE and IMechE
ISPE Young Professionals: ISPE members within 5 years of Graduation of college, University or Apprenticeship