ISPE Highlights
iSpeak Blog
Futureproofing US Pharma Manufacturing Jobs
iSpeak Blog
Limitations of Current Digital Validation Tools
iSpeak Blog
Validation of an Autoclave Cycle
iSpeak Blog
Navigating the PFAS Challenge in Pharma
iSpeak Blog
Futureproofing US Pharma Manufacturing Jobs
iSpeak Blog
Limitations of Current Digital Validation Tools
iSpeak Blog
Validation of an Autoclave Cycle
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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- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
Information Systems
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Management
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Product Development
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- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
- GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
Quality
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- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
Regulatory
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- ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Amgen's Deep Learning Approach to Vial Inspection
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
Supply Chain
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- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
- GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
Facilities & Equipment
Information Systems
Management
Product Development
Quality
Regulatory
Supply Chain
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Amgen's Deep Learning Approach to Vial Inspection
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- GAMP Essentials Certificate
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Navigating the PFAS Challenge in Pharma
- Technology and Innovation: The Spirit of Discovery
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
- GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Amgen's Deep Learning Approach to Vial Inspection
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
- Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
- Technology and Innovation: The Spirit of Discovery
- GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
Conferences
Webinars
Upcoming
On-Demand
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Agile Validation in a GxP environment
Join our next knowledge café Are you also struggling with making your CSV approach (more) agile? Do…
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…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
How to Perform a Compliant Human Error Investigation
Complimentary Learning Level: Advanced Time: 1100 - 1230 EDT Session Length: 1.5 hour Human error…
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Agile Validation in a GxP environment
Join our next knowledge café Are you also struggling with making your CSV approach (more) agile? Do…
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…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
How to Perform a Compliant Human Error Investigation
Complimentary Learning Level: Advanced Time: 1100 - 1230 EDT Session Length: 1.5 hour Human error…
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Agile Validation in a GxP environment
Join our next knowledge café Are you also struggling with making your CSV approach (more) agile? Do…
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…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
How to Perform a Compliant Human Error Investigation
Complimentary Learning Level: Advanced Time: 1100 - 1230 EDT Session Length: 1.5 hour Human error…
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
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…
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
Secrets in the Digital Transformation Vibe
Secrets in the Digital Transformation Vibe Powered and Led by Women in Pharma ® This session…
Improved Data Integrity via Digitization of Environmental Monitoring
Improved Data Integrity via Digitization of Environmental Monitoring Complimentary Learning Level…
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
Quality Culture Matters: Key to Unlocking the Digital Validation Power
Quality Culture Matters: Key to Unlocking the Digital Validation Power Extended Learning Learning…
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…
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Industry News
Latest
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ISPE Members: Volunteer with ISPE
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ISPE Webinar: QRM Based Integrated C&Q Series - Engineering Change Management (ECM)
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Belgian Regulators Sharpen ATMP Expertise
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AI Can Streamline Quality Auditing
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Novartis Plans $23B US Investment
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Buffer Recycling Feasible in Downstream Processes
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Automation, AI Could Cut CGT Production Costs
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Experts Present Framework for PAT in Biopharma Manufacturing
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ISPE Delivers ICH Q12 Training to Singapore's Health Authority
- Coming Soon and Recently Published ISPE Guidance Documents
Community Discussions
Community Discussions
Apr 08, 2025
Validation
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
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...