Welcome Message from President and CEO of ISPE

Jan 31, 2023 8:30am ‐ Jan 31, 2023 8:45am

Innovation in Manufacturing to Address Future Pandemics

Jan 31, 2023 8:45am ‐ Jan 31, 2023 9:15am

Innovation in Manufacturing to Address Future Pandemics
American Pandemic Preparedness Plan focusses on transparency, portfolio approach, partnerships and pivoting. Manufacturing USA is a national network created to secure US leadership in advanced manufacturing. It contains 16 manufacturing innovation institutes covering a broad range of industrial sectors relevant to pandemic response and preparedness. The network leverages large-scale public-private collaboration on technology, supply chain, and workforce development and it includes two recent announcements of grants for advanced research to address the COVID pandemic.


Innovating to Reinvent Medicine for a Healthier World

Jan 31, 2023 9:15am ‐ Jan 31, 2023 9:45am

Cost of Capital for FoF

Jan 31, 2023 9:45am ‐ Jan 31, 2023 10:15am

Aseptic Risk Mitigation Strategies for ATMPs

Jan 31, 2023 10:45am ‐ Jan 31, 2023 11:15am

Pharma 4.0 6th Survey - Latest Results and Trends

Jan 31, 2023 10:45am ‐ Jan 31, 2023 11:15am

Pharma 4.0 6th Survey – Latest Results and Trends
The Pharma 4.0™ Survey is at its 6th edition and the aim is to get the ISPE Pharma 4.0 SIG yearly update on the state of the art, the goals, the mindset and also the sentiment about 4.0 from the Life Science protagonists.Previous editions have been carried out since 2017, having always around 300 to 400 respondents. We have received meaningful results appreciated by the whole industry, the vendor ecosystem and also by the regulators.Changing with the evolving reality, this edition presents a more structured and focalized set of questions along with a review of the topics suggested from the latest and current events, mainly with reference to concerning benefits and particularly related to Quality and Compliance, as requested by Regulators during our 2022 Annual Conference.


Islands in the (Work) Stream

Jan 31, 2023 11:15am ‐ Jan 31, 2023 11:45am

Islands in the (Work) Stream
Single Use technology is a good way to realize flexible facilities within a short period. By customizing the automation, it is possible to use common standards to shorten the implementation- and test time, as well as a reduction of the effort for qualification. New technologies, like MTP (Module Type Package) will support this approach in the near future. To allow the analyzation of the production data an implementation of interfaces for data exchange with other systems (MES, historian,..) has to be standardized as well.


Utility Analytics – Unlocking the Potential of BAS Data

Jan 31, 2023 11:15am ‐ Jan 31, 2023 11:45am

Lessons Learned Chartering a 4.0 Digital Transformation

Jan 31, 2023 11:45am ‐ Jan 31, 2023 12:15pm

Lessons Learned Chartering a 4.0 Digital Tranformation
Pharma, just like every industry, faces unique opportunities and challenges in deploying Industry 4.0. Opportunities include that innovation is part of our industry DNA as we develop new, life-changing drugs. Many pharma firms also have access to capital to build state of the art new facilities or upgrade existing facilities. On the downside, our industry is highly regulated. Stringent requirements for making changes (improvements), documenting our work, and validating our processes are examples where we can get slowed down as compared to other, less regulated industries. How would you have done things differently if you could start your digital transformation project over? That is the golden question, and it is exactly what this session aims to answer for attendees. This session will provide multiple case studies, real-world lessons, and a "start with the end in mind" strategy to help your next digital project succeed. The session explores topics like increased productivity, governance and internal alignment, impacts on your workforce, modifications to facility design, and the absolute need for unwavering security.


Q&A With Speakers - Track 1: Digital Transformation and Pharma 4.0™

Jan 31, 2023 12:15pm ‐ Jan 31, 2023 12:45pm