ISPE Highlights
iSpeak Blog
ISPE Member Spotlight: Nathan Roman
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
A Regulatory Surveillance and Advocacy Framework
iSpeak Blog
The Journey to Pharma 4.0™: Are We There Yet?
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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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Information Systems
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Management
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Product Development
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Quality
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Regulatory
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Supply Chain
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- 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
- The Journey to Pharma 4.0™: Are We There Yet?
Facilities & Equipment
Information Systems
Management
Product Development
Quality
Regulatory
Supply Chain
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
- 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
- The Journey to Pharma 4.0™: Are We There Yet?
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…
AI as the Catalyst for Biomanufacturing Excellence
AI as the Catalyst for Biomanufacturing Excellence Complimentary Learning Level: Intermediate Time…
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…
AI as the Catalyst for Biomanufacturing Excellence
AI as the Catalyst for Biomanufacturing Excellence Complimentary Learning Level: Intermediate Time…
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…
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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Validation of an Automated Glassware Washer
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ISPE GAMP® Good Practice Guide: Computerized GCP Systems and Data (Second Edition)
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ADCs Require Robust Manufacturing Strategies
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Piramal to Expand in Mich., Ky.
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BMS to Invest $40B in US Manufacturing, R&D
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Roche Plans Expansion at Ind. Diagnostics Facility
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Genentech to Build Manufacturing Facility in N.C.
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How to Choose Between Freezing, Lyophilizing
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ISPE Announces Facilities of the Year for 2025
- ISPE Training: Pharma Water Generation USP WFI and Purified Water, Online Live, 13-16 May
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...