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2022 ISPE Annual Meeting & Expo

SES205 - Concurrent Session: Coping with Data Integrity & Digitalizat

Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


Globalization, pandemic, and digital transformation have been the key players of the past decade within the pharma manufacturing environment, generating a complex landscape to navigate. While regulated firms are forced to rely on suppliers and outsourced processes, it is also true that digitization is never really over: to manage and meet realistic product and technology expectations, companies should leverage strong supplier knowledge, data integrity surveillance programs, and avoid bottlenecks in their decision-making processes. Emphasizing the current impact and stress on the supply chain, the presentations of this session are intended to offer a concrete holistic approach to guarantee resilience, product quality, the accelerated construction of the facilities for new therapies, and last but not least, patient safety. The speakers will provide a clear overview of the main lessons learned, new approaches for business plans, and case studies related to fast-track projects designed to provide manufacturing capacity for a growing market such as virotherapy.


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