PAT and Quality by Design 2014

PAT and Quality by Design 2014 covers topics such as:

• How to implement the most effective QBD process in order to maximise profit and case studies from leaders in the industry on how this has been done
• What the regulators expect from filings and how this can be achieved, with key updates on current regulatory requirements along with results from the latest FDA/EMA parallel pilot study
• The implementation of QBD in the generic industry: how the industry are coping with the mandatory requirement
• The future of Qbd in Biologics: overcoming the problems of heterogeneity and data variation
• Moving from batch manufacturing to continuous manufacturing, how to effective implement this, how this will aid quality by design and overcoming the problem of defining a batch
• Latest advances in PAT technology and the best implementation practice of these techniques