Adopting Continuous Manufacturing:
Defining the Platform for Success
in association with AlChE, IDA, IChemE, IEI, ISPE, PMTC, SFI
Adoption of CM has been encouraged by regulators in most regions. Implementation within existing batch facilities has posed challenges that require proactive steps to make this adoption a reality. As such, pharmaceutical sites in Ireland play a key role in facilitating CM adoption. Coordinating the industrial and academic sectors in Ireland with the broader global regulatory community is necessary for this wide scale evolution to occur.
This workshop, supported by the SSPC, is the second in a series following the US-based FDA- AlChE workshop in March 2016. It focuses on specific elements needed to successfully deliver continuous manufacturing projects for API, such as:
Regulatory considerations; expectations for filing and process validation across the product lifestyle
Control strategy and opportunities for process control, including application of PAT
Industry/academic collaboration for shared learning and to address open questions.
Breakout sessions involving all parties will discuss open issues and seek progress towards solutions as the workshop proceeds.
A tour of a live operating continuous manufacturing facility will be available for the first 150 registrants.
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