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Discover, Delve, and Develop: Expert Workshops at the 2023 ISPE Annual Meeting & Expo

ISPE

™, Quality Risk Management (QRM), Contamination Control Strategy (CCS) and Annex 1, Facility Design and Operations, Artificial Intelligence and Machine Learning, and Professional Development. This workshop; ICH Q9(R1) and Quality Risk Management , will feature a detailed summary of ISPE’s ICH Q9 Special Interest Group and their activities.

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Annex 1 in Force! Join the First Discussion after the 25 August Effective Date

ISPE

The recent Annex 1 and discussions leading to this update in regulation have brought about a significant change that punctuates the landscape of pharmaceutical engineering, and it plays out in equipment and how drug product manufacturers are taking steps to achieve product quality. What Will Be Most Valuable to Attendees?

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How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle

ISPE

Whether for risk assessment or optimization, process simulation aims to represent a chemical or biochemical process by modeling the governing mechanisms that affect quality, yield, throughput, environmental impact, and related outcomes under a variety of scenarios. Bioseparations science and engineering. Register Now! Melton, and E.

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A Closer Look at Paperless Validation’s Impact on Biotech

ISPE

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. The continued use of paper validation in a Pharma 4.0

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Regulatory Insights from 2022 ISPE Annual Meeting

ISPE

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. A presentation on ISPE’s Pharma 4.0®

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2023: A Promising Year for ISPE’s Women in Pharma®

ISPE

Tapping into emotional intelligence, sustainability, and the importance of embracing diversity, equity, and inclusion, Women in Pharma programming continues to drive the group’s vision for a more equitable pharmaceutical industry, where diversity of thought thrives. Learn More & Get Involved Women in Pharma

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2023: A Promising Year for ISPE’s Women in Pharma®

ISPE

Tapping into emotional intelligence, sustainability, and the importance of embracing diversity, equity, and inclusion, Women in Pharma programming continues to drive the group’s vision for a more equitable pharmaceutical industry, where diversity of thought thrives. Learn More & Get Involved Women in Pharma

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