25-26 May 2010
London, UK
Pharma IQ is delighted to announce the inaugural PAT and Quality by Design for biopharmaceuticals, being held in London on the 25th-26th May 2010. With PAT and quality by design techniques now established within the small molecules field the focus is shifting to application within the biopharmaceuticals arena, with key regulatory bodies such as the FDA and EMEA actively getting involved I pilot case studies.
This event will bring together professionals specifically tasked with implementing PAT and QbD tools and techniques specifically within the bioprocess and bioproduction area.
Agenda
- Design space validation for a bio products: Establishing a step by step design and validations process
- Process monitoring tools and applications: How to successfully manipulate NIR for large molecule assessment
- Risk assessment and risk control modelling in QbD
- Setting critical quality attributes (CQA) for biopharmaceutical products: Highlighting the challenges and how to overcome them
- Understanding the importance of using multi-variate data analysis for biopharmaceutical QbD support – in-line and online monitoring
- Using PAT and QbD to aid scale-up: How can QbD actually help facilitate scale up?
- Understanding the regulations surrounding PAT and QbD application for biopharmaceuticals and the application in ICH Q8-10
- Advantages of QbD approach for biological products: Can this truly help with quality prediction?
(Subject to change)
Tel: +44 207 368 9300
Email: enquire@iqpc.co.uk
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