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The International Society for Pharmaceutical Engineering (ISPE) has announced ISPE AI®, a multifaceted approach to supporting the industry in AI readiness. This includes the launch of an Artificial Intelligence (AI) Community of Practice (CoP). ISPE provides resources to aid the pharmaceutical industry in realizing the potential of AI through identifying and bringing forth best practices, liaising with regulatory bodies, and communicating lessons learned and case studies with relevant stakeholders. Explore the resources below to learn more.
PE Articles
Future Labs. Strategies for designing and building laboratories that adapt, innovate, and thrive.
In the fast-evolving life sciences sector, lab design, functionality, and technology integration are…
Video
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control…
iSpeak Blog
Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
Exploring the Impact of AI and ML Across the Biotechnology Lifecycle As biotechnology continues to…
News
Alternatives to Testing Sterility in Cell- and Tissue-Based Products
Manufacturers of cell- and tissue-based products are constantly striving to find the right balance…
News
Amgen's Deep Learning Approach to Vial Inspection
Traditional automatic visual inspection (AVI) can yield false rejections up to 20 percent, by some…
News
Amgen Bets on Agility in the Age of AI
Oliver Thiel, Vice President of Operations Commercialization with Amgen, connected with…
iSpeak Blog
Introducing the ISPE Artificial Intelligence (AI) Community of Practice (CoP) Applications, Models, and Data Subcommittee: Pioneering Responsible AI in GxP Environments
Used correctly in the pharmaceutical industry, artificial intelligence (AI) has the possibility to…
Video
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection…
iSpeak Blog
Unlocking the Future of Pharma: Mentor ISPE Launches Expert Webinar Series with a Deep Dive into Machine Learning (ML)/Artificial Intelligence (AI) Case Studies
Mentor ISPE, powered and led by Women in Pharma ®, is leveling up in 2025 with a powerful new…
PE Articles
Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development
Pharmaceutical companies can no longer rely on traditional drug development methods to keep pace…
PE Articles
Transforming Biopharma: AI and Digital Transformation Center Stage at 2025 ISPE Biotechnology Conference
The 2025 ISPE Biotechnology Conference, scheduled for 2–3 June in Boston, MA, US, and virtually…
Video
AI as the Catalyst for Biomanufacturing Excellence
AI as the Catalyst for Biomanufacturing Excellence Complimentary Learning Level: Intermediate…
PE Articles
Future Labs. Strategies for designing and building laboratories that adapt, innovate, and thrive.
In the fast-evolving life sciences sector, lab design, functionality, and technology integration are…
Video
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control…
iSpeak Blog
Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
Exploring the Impact of AI and ML Across the Biotechnology Lifecycle As biotechnology continues to…
News
Alternatives to Testing Sterility in Cell- and Tissue-Based Products
Manufacturers of cell- and tissue-based products are constantly striving to find the right balance…
News
Amgen's Deep Learning Approach to Vial Inspection
Traditional automatic visual inspection (AVI) can yield false rejections up to 20 percent, by some…
News
Amgen Bets on Agility in the Age of AI
Oliver Thiel, Vice President of Operations Commercialization with Amgen, connected with…
iSpeak Blog
Introducing the ISPE Artificial Intelligence (AI) Community of Practice (CoP) Applications, Models, and Data Subcommittee: Pioneering Responsible AI in GxP Environments
Used correctly in the pharmaceutical industry, artificial intelligence (AI) has the possibility to…
Video
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection…
iSpeak Blog
Unlocking the Future of Pharma: Mentor ISPE Launches Expert Webinar Series with a Deep Dive into Machine Learning (ML)/Artificial Intelligence (AI) Case Studies
Mentor ISPE, powered and led by Women in Pharma ®, is leveling up in 2025 with a powerful new…
PE Articles
Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development
Pharmaceutical companies can no longer rely on traditional drug development methods to keep pace…
Guidance Documents
Artificial Intelligence (1)
+Data Integrity (1)
+GAMP® (1)
+Community Discussions
Community Discussions
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Jan 27, 2025
Information Systems
Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Pharmaceutical Engineering Magazine Articles
Emerging Leaders Editorial: Career Development Powered by AI
The healthcare field is being transformed by artificial intelligence (AI) in remarkable ways…
ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma
ChatGPT and other large language models are positioned to change the world. They can also shift…
The Road to Explainable AI in GXP-Regulated Areas
Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with…
Applying GAMP® Concepts to Machine Learning
This article explores life-cycle activities for machine learning (ML) within regulated life sciences…
AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many…
Transforming Biopharma: AI and Digital Transformation Center Stage at 2025 ISPE Biotechnology Conference
The 2025 ISPE Biotechnology Conference, scheduled for 2–3 June in Boston, MA, US, and virtually…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Pharmaceutical Engineering® Article Wins 2024 APEX Award
ISPE has been honored with a 2024 APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other…
ISPE Announces ISPE AI®
ISPE recently announced ISPE AI ®, an initiative aimed at aiding the pharmaceutical industry in…
Artificial Intelligence Governance in GxP Environments
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from…
Machine Learning Risk and Control Framework
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
New EU AI Regulation and GAMP® 5
This article describes how ISPE GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized…
Emerging Leaders Editorial: Career Development Powered by AI
The healthcare field is being transformed by artificial intelligence (AI) in remarkable ways…
ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma
ChatGPT and other large language models are positioned to change the world. They can also shift…
The Road to Explainable AI in GXP-Regulated Areas
Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with…
Applying GAMP® Concepts to Machine Learning
This article explores life-cycle activities for machine learning (ML) within regulated life sciences…
AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many…
Transforming Biopharma: AI and Digital Transformation Center Stage at 2025 ISPE Biotechnology Conference
The 2025 ISPE Biotechnology Conference, scheduled for 2–3 June in Boston, MA, US, and virtually…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Pharmaceutical Engineering® Article Wins 2024 APEX Award
ISPE has been honored with a 2024 APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other…
ISPE Announces ISPE AI®
ISPE recently announced ISPE AI ®, an initiative aimed at aiding the pharmaceutical industry in…
Artificial Intelligence Governance in GxP Environments
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from…
iSpeak Blog Posts
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