Annex 1 is not a checklist… It’s a system of decisions, and the CCS is its backbone. For years, compliance in sterile manufacturing was often approached as a destination. A milestone reached once the documents were approved, the equipment qualified, and the inspectors satisfied. The 2022 revision of EU/PIC/s GMP Annex 1 changed that paradigm….
Annex 1 is not a checklist Read More »
Conversations That Matter No deviation’s Takeaways from 2025 ISPE Conference in Singapore Panelists: Dave O’Connor, C&Q Digital Transformation Manager, No deviation, Hazem Eleskandarani, Senior Director, Global Quality Engineering, CSL Behring, Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Sebastian Scheler, MD & Chief Methodologist, Innerspace, Yiming Peng, Global Data Science Lead,
Implementing a Risk-based Approach & Benefits and Challenges of Digital Tools Read More »
The ISPE Singapore Affiliate Conference & Exhibition 2023 hosted a pivotal panel discussion titled “Digital Pharma Panel: Challenges to Digital ‘Emancipation’. This engaging session gathered renowned experts from the pharmaceutical industry to delve into the multifaceted challenges and opportunities posed by digital transformation. Panelists: Atul Tripathi Associate Director, Emerson Automation Solutions, Singapore Francesco Ferri OT
8 Takeaways from Digital Pharma Panel: Challenges to Digital ‘Emancipation’ Read More »
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