Maximise cost efficiency, improve quality and cut waste through Quality by design
80% of companies plan to invest in Quality by Design and PAT solutions, yet 72% do not have a fully established process in place. But what is the reason for this gap? 59% of people stated it was due to internal lack ofexpertise.
This is where we come in. For the past 11 years, Pharma IQ’s annual conference has been bringing you the latest case studies to help show you how to effectively implement Qbd into your company. This year is no different with 16 key regulators and leading representatives from across pharma, generic and the biologic industry who can share with you practical strategies for putting a successful process in place. Plus brand new this year hear about how other industries implement Qbd and what the role of continuous manufacturing has in aiding the process.
What’s more the event will outline the regulatory requirements associated with quality by design, allowing for a smoother and more efficient approval process. It is these discussions and interactions with regulators which will help shape the future of successful approvals within your company.
That’s why we’ve built this year’s agenda to not only focuson the implementation of Qbd, but the regulatory requirements of implementation.
Key topics include:
- 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
- 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
- The future of Qbd in Biologics: overcoming the problems of heterogeneity and data variation
- The implementation of QBD in the generic industry: how the industry are coping with the mandatory requirement
- Latest advances in PAT technology and the best implementation practice of these techniques
- 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