Venue: CCT at Smithfield, London Description: Developing an in-house strategy for PAT and QbD application specifically for biopharmaceutical products 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  Process monitoring tools and applications: How to§and validations process   Risk assessment and§successfully manipulate NIR for large molecule assessment   Setting Critical Quality Attributes (CQA) for§risk control modelling in QbD –  biopharmaceutical products: Highlighting the challenges and how to overcome them  Understanding the importance of using multi-variate data analysis for§–   Using PAT and§Biopharmaceutical QbD support – in-line and on-line monitoring  §QbD to aid scale-up: How can QbD actually help facilitate scale up?  Understanding the regulations surrounding PAT and QbD application for  Advantages of QbD approach§Biopharmaceuticals and the application in ICH Q8-10  for biological products: Can this truly help with quality prediction? (Subject to change) Tel: +44 207 368 9300 Email: enquire@iqpc.co.uk

 

More information is available at http://www.biopatandqbd.com/Event.aspx?id=259248&utm_source=DiaryListings&utm_medium=online&utm_campaign=DiaryListings&MAC=18559.001DL

Source: web of pharmaoutsourcing