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Quality by Design


Monday, February 24, 2014 - Tuesday, February 25, 2014
Marriott Regents Park Hotel, 128 King Henry's Road
London, United Kingdom

http://atnd.it/1i1O9ro

Event Type: Conference

 

Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.Why attend this event:•Employ QbD to design a formulation process. Harness raw material analysis and control strategy •Utilise PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs •Use risk assessment and management to best effect •Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500 •Apply multivariate data analysis to maximise product development and patient outcomes.

 

Artists / Speakers: Julian Morris, Andreas Schreiner, Marcel de Matas, Frank Thielman, Martin Schubert, Michel Ulmschneider, Simeone Zomer, Peter Boogaard.

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