You'll know from previous posts that FDA-AIChE organized a first successful workshop on adoption of CM in Besthesda in February 2016. That is to be followed just under one year later by a second workshop in Ireland on 22-23 February, 2017.
Like the first workshop, this one will bring together the 'doers' in adopting CM; that is:
Like the first workshop, this one will bring together the 'doers' in adopting CM; that is:
- site leaders and senior managers from pharma manufacturing sites;
- leading scientists and engineers driving adoption from HQ and locally;
- regulators including reviewers and inspectors and members of emerging technology teams;
- and leading investigators from collaborative research centers worldwide.
We will spend two days together hearing the latest updates and progress from industry practitioners, regulators and principal investigators, and in breakout sessions and a tour of a live operating CM facility for drug substance. All talks and discussions will address three core themes:
- Regulatory considerations: expectations for filing and process validation across the product lifecycle (especially how CM differs from batch)
- Control strategy, including application of PAT
- (Opportunities for) Industry / academic collaboration for shared learning and to address open questions.
Those interested in progressing CM filings, the future of pharmaceutical manufacturing and looking to have an influence or make a contribution in this field will find this workshop valuable and informative. We look forward to seeing you there.
Online registration and further details of the program will be available shortly. If you'd like more details in the meantime, contact contact co chairs Mark Barrett (APC) and Joe Hannon (Scale-up Systems).