ISPE Highlights
iSpeak Blog
Validation of an Automated Glassware Washer
iSpeak Blog
ISPE Member Spotlight: Nathan Roman
iSpeak Blog
When Analytics Meet Quality
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework
iSpeak Blog
The Journey to Pharma 4.0™: Are We There Yet?
iSpeak Blog
Validation of an Automated Glassware Washer
iSpeak Blog
ISPE Member Spotlight: Nathan Roman
iSpeak Blog
When Analytics Meet Quality
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework
Pharmaceutical Engineering Magazine
Guidance Documents
Highlights From ISPE Knowledge Network
Explore webinars, training PE articles, and more relevant to your job function.
These top focus areas bring the most relevant ISPE content to the forefront of your browsing experience. Explore webinars, training, PE articles and more.
Facilities & Equipment
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Information Systems
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Management
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Product Development
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Quality
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Regulatory
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Supply Chain
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- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Facilities & Equipment
Information Systems
Management
Product Development
Quality
Regulatory
Supply Chain
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
- When Analytics Meet Quality
- Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
- Pharmaceutical Engineering® Reader Picks for April 2025
- Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Conferences
Webinars
Upcoming
On-Demand
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Complimentary Learning Level…
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…
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Time…
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
Life Cycle Approach to Process Validation- Stage 3 Implementation
Life Cycle Approach to Process Validation- Stage 3 Implementation Complimentary Learning Level…
QRM Base Integrated C&Q Series - User Requirement Specification
QRM Base Integrated C&Q Series - User Requirement Specification Complimentary Learning Level…
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems Complimentary…
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing…
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Complimentary Learning Level…
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…
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Time…
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
Life Cycle Approach to Process Validation- Stage 3 Implementation
Life Cycle Approach to Process Validation- Stage 3 Implementation Complimentary Learning Level…
QRM Base Integrated C&Q Series - User Requirement Specification
QRM Base Integrated C&Q Series - User Requirement Specification Complimentary Learning Level…
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems Complimentary…
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing…
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Complimentary Learning Level…
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…
Holistic Pharma 4.0 Digital Maturity Assessment
Holistic Pharma 4.0 Digital Maturity Assessment Complimentary Learning Level: Basic Session Length…
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation Complimentary Learning Level…
ISPE Tariff Forum
ISPE Tariff Forum Learning Level: Intermediate Session Length: 1.5 hours The ISPE Oral Solid Dosage…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
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…
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q…
Navigating the PFAS Challenge in Pharma: Regulatory Landscape, Risk Management, and Health Implications
Complimentary Learning Level: Intermediate Session Length: 1 hour Per- and polyfluoroalkyl…
Complimentary Member Orientation and Benefits Webinar
Join us for the complimentary ISPE Member Orientation and Benefits webinar to unlock your membership…
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory…
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense Complimentary…
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning &…
Holistic Pharma 4.0 Digital Maturity Assessment
Holistic Pharma 4.0 Digital Maturity Assessment Complimentary Learning Level: Basic Session Length…
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation
CSV vs CSA: GAMP 5's Actionable Steps to Transitioning Your Validation Complimentary Learning Level…
ISPE Tariff Forum
ISPE Tariff Forum Learning Level: Intermediate Session Length: 1.5 hours The ISPE Oral Solid Dosage…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
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Industry News
Latest
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ISPE Training: Aseptic Processing and Annex 1 Training Course, Online Live, 19-22 May
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Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
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Some Drug Developers Reconsider Regulatory Approval Pathways
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What Inspectors Look for in QRM
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Global Council Drafts AI guide for Pharmacovigilance
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Roche Commits $300M for Biopharma Production in China
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AstraZeneca Opens $300M Cell Therapy Plant in Md.
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Mass Photometry May Accelerate Viral Vector Production
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Simplification Prevents Biopharma Startup Failure
- Digital Transformation, Sustainability Make Touchlight DNA Hub a FOYA Winner
Community Discussions
Community Discussions
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Latest Magazine Issue
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to workforce development. This article proposes a skill...