PE Magazine | July / August 2024
Artificial Intelligence Governance in GxP Environments

Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from drug discovery through manufacturing. The nature of AI and concerns of bias, privacy, transparency, and security in a regulated industry necessitate a governance framework to ensure concerns are controlled using “guardrails.”

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PE Magazine | July / August 2024
Room Differential Pressures in Facility Design: Fundamentals

The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures.

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iSpeak Blog | 22 August 2024
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce

The unstoppable progress in technology and scientific knowledge is reshaping our industry.

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Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
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Facilities & Equipment
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. 2024 ISPE FOYA Category Winner for Social Impact: Chugai Pharma Manufacturing Co., Ltd.
  4. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
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Information Systems
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
  4. Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
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Management
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  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
  4. Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
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Product Development
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
  4. ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
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Quality
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Global Convergence Opportunities
  4. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
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Regulatory
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Global Convergence Opportunities
  4. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
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Supply Chain
  1. Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
  2. Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
  3. Global Convergence Opportunities
  4. Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
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Conferences

2024 ISPE Annual Meeting & Expo

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Kissimmee, FL US

2024 ISPE Pharma 4.0™ and Annex 1 Conference

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Rome, Italy IT

2025 ISPE Facilities of the Future Conference

San Francisco, CA US

2025 ISPE Aseptic Conference

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ARLINGTON, VA US

2025 ISPE Europe Annual Conference

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London, GB

2025 ISPE Biotechnology Conference

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Boston, MA US
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Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
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The Use of Engineering Change Management (ECM)
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Women in GAMP®
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ALCOA++: Leveling Up Data Integrity
ALCOA++: Leveling Up Data Integrity Complimentary Time: 1100 - 1200 EDT Session Length: 1 hour ALCOA…
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations
Unique Glass Primary Containers Identification in Pharmaceutical Fill & Finish Operations…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Time: 1600…
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
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AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
Digital Display Labeling in Clinical Trial Supply Chains
Digital Display Labeling in Clinical Trial Supply Chains Complimentary Learning Level: Basic Session…
Connecting ATMP Discovery to Commercial: Improving Manufacturability
Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level…
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations
Driving Operational Excellence: Lean Six Sigma Integration in Complex CMO Operations Complimentary…
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
Complimentary Member Orientation and Benefits Webinar
Complimentary Learning Level: Basic Session Length: 1 hour Join us for the complimentary ISPE Member…
Design, Install & Maintain a Pharmaceutical Compressed Air System
Design, Install & Maintain a Pharmaceutical Compressed Air System Complimentary Learning Level…
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Fireside Chat on Transfers According to Annex 1
Fireside Chat on Transfers According to Annex 1 Complimentary Learning Level: Intermediate Session…
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets…
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Training Courses

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2024 ISPE Pharma 4.0™ and Annex 1 Conference - Training
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Rome, IT
Bethesda | Oct 2024
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North Bethesda, MD US
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
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Strasbourg, FR
ISPE Hands-On Aseptic Processing & Annex 1 Training Course
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Strasbourg, FR
ISPE Hands-On Commissioning & Qualification (C&Q), Process Validation, and ATMP Training
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Strasbourg, FR
2024 ISPE Annual Meeting & Expo - Training
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Orlando, FL US
2024 ISPE December Online Live Training
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Online Live, US
2024 ISPE November Online Live Training
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Online Live, US
2024 ISPE October Online Live Training
Online Live, US
2024 ISPE September Training
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Online Live, US
2025 ISPE February Online Live Training
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Online Live, US
2024 ISPE November In Person Training
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North Bethesda, MD US
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July / August 2024

July / August 2024

The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale. Meanwhile, the...
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