PE Magazine | May / June 2024
Cell Culture Media Manufacturing Controls for Bio-Manufacturing

Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C&GTs) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries.

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iSpeak Blog | 20 June 2024
Common Technical Document (CTD) Challenges in Emerging Markets

Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies.

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iSpeak Blog | 30 May 2024
Practice the ISPE Good Practice Guide Series – Expert Workshops at the 2024 ISPE Annual Meeting & Expo

Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed a robust workshop program, taking place Sunday, 13 October 2024.

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ISPE Highlights

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Common Technical Document (CTD) Challenges in Emerging Markets
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Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality
Evdokia Korakianiti
Ultragenyx
Digital Transformation at the 2024 ISPE Annual Meeting & Expo
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Highlights From ISPE Knowledge Network

Explore webinars, training PE articles, and more relevant to your job function.
 
Facilities & Equipment
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. De-Risking Aseptic Processing Operations: Insights from the 2024 ISPE Europe Annual Conference
  3. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  4. Sustainable Pharma Labs Using Green Chemistry
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Information Systems
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. European Initiatives to Advance Manufacturing Digitalization
  3. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  4. Advancing Digital Transformation at the 2024 ISPE Annual Meeting & Expo
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Management
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  3. Register Now for the 2024 ISPE Annual Meeting & Expo
  4. ISPE Women in Pharma® Member Spotlight: Hilal Yamaner
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Product Development
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  3. ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
  4. Register Now for the 2024 ISPE Annual Meeting & Expo
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Quality
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  3. ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
  4. Register Now for the 2024 ISPE Annual Meeting & Expo
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Regulatory
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. US FDA Views on QRM in Design, Control, and Maintenance
  3. Regulators on Annex 1 Implementation
  4. Common Technical Document (CTD) Challenges in Emerging Markets
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Supply Chain
  1. Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
  2. Learn the Blank Slate to Building Excellence at the 2024 ISPE Biotechnology Conference
  3. Register Now for the 2024 ISPE Annual Meeting & Expo
  4. Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals.
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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, 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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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…
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Time: 1000 - 1100 EDT Session Length: 1 hour Asset Life Cycle…
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers
Mechanical Recycling of Post-Use Bioprocessing Plastic Containers Complimentary Learning Level…
Digital Display Labeling in Clinical Trial Supply Chains
Digital Display Labeling in Clinical Trial Supply Chains Complimentary Learning Level: Basic Time…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Time: 1600…
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Time: 0800…
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
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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…
Unique Aspects of OOS Investigations Related to Biotech Products
Unique Aspects of OOS Investigations Related to Biotech Products Complimentary Learning Level…
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape…
Future of Analytical Procedures – ICH Q2(R2) & Q14: Development, Validation, & Lifecycle Management
Future of Analytical Procedures – ICH Q2(R2) & Q14: Development, Validation, & Lifecycle Management…
Empowering Voices: Creating a More Inclusive Pharmaceutical Industry & Patient Experience
Complimentary Learning Level: Basic Session Length: 1 hour As the healthcare landscape evolves, it's…
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Booklet Labels
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Decommissioning Pharma Equipment & Facilities
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Development of Investigational Therapeutic Biological Products
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Harmonizing the Definition and Use of NIMPs
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HVAC & Process Equipment Air Filters
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Interactive Response Technology
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Management of Engineering Standards
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Operations Management
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Ozone Sanitization of Pharma Water Systems
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Packaging, Labeling, & Warehousing Facilities
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Process Validation
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Process Gases
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Project Management for the Pharmaceutical Industry
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Quality Lab Facilities
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Sampling Pharma Water, Steam, & Process Gases
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Single-Use Technology
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