PE Magazine | July / August 2024
Data Analysis of Contamination Control Strategies for Production

On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant regulatory changes, including the requirement of a documented contamination control strategy (CCS).

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PE Magazine | July / August 2024
Acceptable Discoloration Levels on Pharmaceutical Weld Beads

Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods.

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iSpeak Blog | 6 September 2024
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo

As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry leaders is more crucial than ever.

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2024 ISPE Annual Meeting & Expo View Agenda Guidance Documents 75+ documents available Membersip Join 22,000+ members

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Facilities & Equipment
  1. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  2. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
  3. Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
  4. Pharma 4.0™ and Annex 1 – The Perfect Fit
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Information Systems
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  2. Dynamic Data Integrity: Why Alcoa Keeps Evolving
  3. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
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Management
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  3. Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
  4. Pharma 4.0™ and Annex 1 – The Perfect Fit
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Product Development
  1. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  2. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
  3. Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
  4. Pharma 4.0™ and Annex 1 – The Perfect Fit
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Quality
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  2. A Holistic Mindset is Key to Supply Resiliency
  3. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
  4. September / October 2024
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Regulatory
  1. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  2. A Holistic Mindset is Key to Supply Resiliency
  3. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
  4. September / October 2024
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Supply Chain
  1. Explore AI Solutions and Pursue Digital Transformation-Related Technology Advancements in the Pharmaceutical Industry: Join the 2024 ISPE Annual Meeting & Expo
  2. Explore Cutting-Edge Workshops on Trends in the Pharmaceutical Industry, Pharmaceutical Technology Advancements Including AI, and More at the 2024 ISPE Annual Meeting & Expo
  3. Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
  4. Pharma 4.0™ and Annex 1 – The Perfect Fit
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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

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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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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…
ISPE FOYA Submission Best Practices
ISPE FOYA Submission Best Practices Complimentary Learning Level: Basic Time: 1100 - 1200 EDT…
AI/ML in Regulated Life Sciences (GxP) Sectors - Computerized System Integration and Acceptance
AI/ML in Regulated Life Sciences (GxP) Sectors - Computerized System Integration and Acceptance…
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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Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers Complimentary Learning Level…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
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…
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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
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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Latest Issue

September / October 2024

September / October 2024

PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry...
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