ISPE

ISPE France Conference

From Uncertainty to Reality: Validating AI and Gen AI in the Pharmaceutical Industry

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Conversations That Matter No deviation’s Takeaways from 2025 ISPE France Conference – Validation of AI in the pharmaceutical industry. Presentation of a validation strategy for AI systems (hybrid and generative) in GxP environments, aligned with GAMP 5 2nd edition. Speaker : Filipa Silva – Capgemini Engineering Artificial Intelligence (AI) and Generative AI (Gen AI) are…

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Conversation that matters

An overview of the ISPE Good Practice Guide (GPG) for Digital Validation

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Conversations That Matter No deviation’s Takeaways from 2025 ISPE Conference in Singapore Speaker: Dave O’Connor, C&Q Digital Transformation Manager at No deviation, One of the authors of the new ISPE Good Practice Guide author on digital validation. “Four years ago, I was still working with paper.” That’s how Dave O’Connor, an author of the ISPE

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Building a Smarter Regulatory Future: Innovation, Access, and the Fight Against AMR

Building a Smarter Regulatory Future: Innovation, Access, and the Fight Against AMR

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Conversations That Matter No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London  Speaker: Dr. Evdokia Korakianiti – Head of the Quality and Safety Department at the European Medicines Agency (EMA) At this year’s ISPE Europe Annual Meeting, Dr. Evdokia Korakianiti delivered a timely message: we are at a unique regulatory inflection point in Europe—one

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ISPE Training Annexe 1

The challenges in Annex 1 Implementation

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Conversations That Matter No deviation’s Takeaways from the ISPE Training on Annex 1 Implementation and First Inspector Findings At the recent ISPE training on Annex 1 Implementation and First Inspector Findings, speakers Tracy Moore (TM Pharma Group Ltd) and Richard Denk (SKAN AG) shared their insights on the progress of the industry’s adoption of the

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Conversation That Matters

Who Owns Compliance? Shared Responsibility in the SaaS Era

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Conversations That Matter No deviation’s Takeaways from ISPE France Conference – Evolution of Supplier Relationships in Regulated SaaS Environments Topic: A deep dive into how the supplier-client relationship is evolving in SaaS solutions for regulated industries like pharmaceuticals—focusing on the critical shift toward true partnership and shared responsibility. Speaker: Philippe Lenglet – Dassault Systèmes 3DS

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ISPE Good Pratice Guide: Digital Validation

ISPE’s Good Practice Guide is out — and No deviation Is Proudly Involved

1 Comment / Blog, Digitalization, Paperless Validation, Validation /

Digital Validation Takes Center Stage April 2025 marks a major milestone in the pharmaceutical and life sciences industries: the publication of ISPE’s Good Practice Guide: Digital Validation. This long-anticipated resource provides clear, actionable guidance on transitioning from traditional paper-based validation to fully integrated Digital Validation Tools (DVTs). At No deviation, we’re particularly proud of this

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