Regulators Uncover Best Practice PAT and QbD for Successful Submission Rates
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PAT & QbD Summit
With QbD becoming a normal integrated part of most companies these days, it is important not to be left behind. Understanding regulatory requirements, PAT data and what will drive companies to have a cost efficient QbD process are all key. Yet still companies are struggling to have a fully implemented QbD system in place. Fifty-nine per cent of people said this was down to lack of internal expertise. Later this month, experts will meet at the PAT and Quality By Design Summit to discuss submission rates and cost saving QbD processes.
The PAT and Quality By Design Summit will ensure attendees hear the latest case studies from industry experts on how they are implementing QbD plus hear from leaders in other industries on their implementation process and how this can be applied to pharma.
Join thought leaders at The 11th Annual Conference to:
• Understand how to prepare a successful QbD submission with regulatory expertise from FDA’s Lawrence Yu and ex-EMEA’s John Purves.
• Implement QbD in your company: find out how this has been done by experts in Merck, Teva and Bristol Myers Squibb.
• Overcome the problems with implementing QbD in biologics: hear how this has been done in Lonza.
• Implement continuous manufacturing with practical advice from the latest pilot plants from Novartis and GlaxoSmithKline.
• Understand how the generics industry has complied with the mandatory QbD regulations and the benefits of this within Teva.
Confirmed companies include the FDA, Teva, Merck Serono, EMEA, GlaxoSmithKline, the Centre for Process Analytics and Control Technology, Lonza and many more.
Find the full programme, speaker list and registration form at http://bit.ly/1g2NTL6, call +44 20 7036 1305 or email enquire@iqpc.co.uk. This event will be sponsored by Siemens and Parker.