PE Magazine | March / April 2024
A Sustainable Approach to Steam Quality Management

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. 

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iSpeak Blog | 17 April 2024
Lean Stability Strategies and Best Practices Discussed during Webinar

Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5.

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iSpeak Blog | 5 April 2024
Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering

The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities.

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Guidance Documents 75+ documents available Community Forums 100+ discussions happening Women in Pharma® International Womens Day #InspireInclusion

ISPE Highlights

Peyton Myers
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
AM23 Hackathon participants
ISPE Foundation Professional Development Grant Recipient Silas Tamufor
Quality Management Maturity
Roundtable Discussion – Lean Stability
Guidance Documents
2024 ISPE Aseptic Conference keynote Presentations
Industry 4.0 Machinery Production Facility
DNA strands-by Thomas
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Highlights From ISPE Knowledge Network

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Facilities & Equipment
  1. Guide: 503A Compounding
  2. Highlights from the 2024 ISPE Aseptic Conference
  3. Challenges and Trends in Biopharmaceutical Facility Design
  4. Manufacturing Execution Systems (MES): Beyond ROI, a New Look at Business Payback
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Information Systems
  1. Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
  2. Highlights from the 2024 ISPE Aseptic Conference
  3. Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering
  4. What you need to know about the GAMP track: 2024 ISPE Europe Annual Conference, 16 – 18 April
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Management
  1. GxPs for Leadership
  2. Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future
  3. Lean Stability Strategies and Best Practices Discussed during Webinar
  4. Highlights from the 2024 ISPE Aseptic Conference
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Product Development
  1. Highlights from the 2024 ISPE Aseptic Conference
  2. Understanding the Challenges in Drug Shortages
  3. Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
  4. Advancements in Cell and Gene Therapy Manufacturing
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Quality
  1. GxPs for Leadership
  2. Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
  3. Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence
  4. Lean Stability Strategies and Best Practices Discussed during Webinar
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Regulatory
  1. Highlights from the 2024 ISPE Aseptic Conference
  2. GMP Refresher
  3. March / April 2024
  4. Practical Applications of Current Standards and Regulations in the Context of Digitalization
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Supply Chain
  1. Highlights from the 2024 ISPE Aseptic Conference
  2. Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering
  3. March / April 2024
  4. Understanding the Challenges in Drug Shortages
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Conferences

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
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Webinars

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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…
Complimentary Member Benefits and Orientation Webinar
Complimentary Member Benefits and Orientation Webinar Complimentary Learning Level: Basic Session…
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment…
Acing an Audit: What to Do Before, During, and after an Inspection
Acing an Audit: What to Do Before, During, and after an Inspection Learning Level: Basic Session…
ISPE Expert Xchange GAMP®:  Implementing Data Integrity by Design 
ISPE Expert Xchange GAMP®:  Implementing Data Integrity by Design  Next-Generation Virtual…
ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug & Produce
ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug & Produce Next-Generation Virtual Experience…
ISPE Expert Xchange GAMP®: Realizing the Value in Validation with Critical Thinking and Computer Software Assurance
ISPE Expert Xchange GAMP®: Realizing the Value in Validation with Critical Thinking and Computer…
ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision
ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision Learning Level: Intermediate Session…
ISPE Expert Xchange: Distributed & Decentralised Manufacturing – Moving the Conversation Forward
ISPE Expert Xchange: Distributed & Decentralised Manufacturing – Moving the Conversation Forward…
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Development of Investigational Therapeutic Biological Products
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Process Gases
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Project Management for the Pharmaceutical Industry
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Sampling Pharma Water, Steam, & Process Gases
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